QD Syringe – The Low Dead Space Syringe

Posted on September 29, 2016. Filed under: Syringe Blog | Tags: , , , , , , , , |


The QD Syringe drastically cuts the waste of costly medications down by over 89%, leaving just a scant 18 microliters of residual volume behind. This is a massive money-saving benefit to the healthcare industry and consumers.

Christopher Green designed the Bilateral QD GlyfloTechnology™ for the QD Syringe. The uniquely patented cone-shaped tip has bilateral fluid flow channels and a bilateral orifice. This new design also greatly reduces the risks of needle sticks by medical professionals, reduces the spread of infectious diseases, and saves tremendously on medication waste with its low residual volume design and guarantees delivering a less painful injection to the patient.

The Low Dead Space Syringe – Low Residual Volume Syringe

Syringe with Integrated Cannula – Patent # 9,295,788


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FDA Guide On Approving Medical Devices

Posted on July 30, 2016. Filed under: Syringe Blog | Tags: , , , , , , , , , , , , , , , , , , , , , |

FDA Guidance On Approving Medical Devices

ImageNew FDA guidance on considerations used in device approval, de novo decisions

Clinical data, risks, benefits and patient risk tolerance outlined in process

The U.S. Food and Drug Administration today published a first-of-a-kind guidance for medical device manufacturers, describing how the benefits and risks of certain medical devices are considered during pre-market review.

Premarket approval (PMA) is the FDA process of scientific and regulatory review used to evaluate the safety and effectiveness of Class III medical devices. Class III devices are those that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential unreasonable risk of illness or injury. The de novo process is available for low- and moderate-risk devices that have been found not substantially equivalent (NSE) to existing devices.

When evaluating PMA applications or de novo petitions, the FDA relies upon valid scientific evidence to assess safety and effectiveness. Both clinical and non-clinical data play a role in FDA’s benefit-risk determinations.

The guidance includes a worksheet for device reviewers that incorporates the principal factors that influence benefit-risk determinations, such as the type, magnitude and duration of a risk or benefit, the probability that a patient will experience the risk, patient tolerance for risk, availability of alternative treatments, and the value the patient places on treatment.

The guidance:
  • outlines the systematic approach FDA device reviewers take when making benefit-risk determinations during the premarket review process
  • provides manufacturers a helpful tool that explains the various principal factors considered by the agency during the review of PMA applications, the regulatory pathway for high-risk medical devices, and de novo petitions, a regulatory pathway available for novel, low- to moderate-risk devices
  • describes an approach that takes into account patients’ tolerance for risks and perspectives on benefits, as well as the novelty of the device.

“This guidance clarifies this process for industry, which will provide manufacturers with greater predictability, consistency and transparency in FDA decision-making while allowing manufacturers and the FDA to use a common framework for benefit-risk determinations,“ said Jeffrey Shuren, M.D., director of FDA’s Center for Devices and Radiological Health (CDRH).

The FDA will also increase the transparency of the decision-making processes by describing the worksheet analysis in the Summary of Safety and Effectiveness Data for PMAs and the decision summary review memos for de novo decisions.

“In addition to bringing clarity to our decision making for industry, this guidance will provide our reviewers with uniform and consistent guidelines to assess probable benefits and risks,” said Shuren.

CDRH will train medical officers, review staff managers and device reviewers on the guidance to assure the guidance is applied consistently to submissions and petitions.  CDRH reviewers will begin applying the guidance to incoming PMA and de novo submissions and to submissions already under review with decisions beginning on May 1.

The FDA is also developing external training modules to help industry and device sponsors understand how CRDH will apply the guidance.

For more information:
Medical Device Guidance Documents

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Media Inquiries: Michelle Bolek, 301-796-2973, Michelle.Bolek@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA


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510k Premarket Notification Fees

Posted on June 5, 2012. Filed under: Syringe Blog | Tags: , , , , , , |

Premarket Notification 510k Review Fees


On October 26, 2002 the Medical Device User Fee and Modernization Act of 2002 signed into law. This law authorizes FDA to charge a fee for medical device Premarket Notification 510(k) reviews. This application fee applies to most 510(k)s including Traditional, Abbreviated, and Special 510(k)s, but not those exempted or waived as noted below.

Small businesses may qualify for a reduced fee. Payment must be received on or before the time the 510(k) submission is submitted. If the submitter has not paid all fees owed, FDA will consider the submission incomplete and will not accept it for filing.



The review fees for 510(k) submissions are below:

FY 2012 Device Review User Fees (U.S. Dollars)
Submission Standard Fee Small Business Fee
(≤$100 million in gross receipts or sales)
510(k) $4,049 $2,024
513(g) $2,971 $1,485

The applicable fee corresponds with the date of receipt of the submission by FDA. Please note that FDA will consider the 510(k) submission incomplete and will not accept it for filing until the fee is paid in full. That is, the date of receipt is the date that the submission has been received AND the fee is paid in full.

FDA will adjust these fees each year to account for inflation, changes in workloads, and other factors. The small business fee is 50% of the standard fee. FDA will announce the new fees for the next fiscal year in a Federal Register notice by August 1 of each year.

 Exemptions and Waivers

The following exemptions or waivers apply:

Fee Exemptions and Waivers (No Fee for These)
Category Exemption or Waiver
Third-party 510(k) Exempt from any FDA fee; however, the third-party does charge a fee for its review.
Any application for a device intended solely for pediatric use. Exempt from user fee. Please note that changing the intended use from pediatric use to adult use requires the submission of a new 510(k). The new 510(k) is subject to the 510(k) review fee at the time of submission.
Any application from a State or Federal Government entity. Exempt from any fee unless the device is to be distributed commercially.

When to Pay

Payment must be received at or before the time the 510(k) submission is submitted. If the submitter has not paid all fees owed, FDA will consider the submission incomplete and will not accept it for filing.

 How/Where to Send Payment

Submit the information and payment in the following order
  1. If you believe you qualify as a Small Business and would like to qualify for reduced fees, submit a Small Business Qualification Certification. If you qualify, you will receive a Small Business Decision number. You must provide your Small Business Decision number on the Medical Device User Fee Cover Sheet at the time of submission to be eligible for reduced fees. FDA will not accept reduced fees without a Small Business Decision number and will not refund the difference between the standard fee and the small business fee after the submission has been received.
  2. Complete the Medical Device User Fee Cover Sheet and send a completed copy with your payment.
  3. Submit your Premarket Notification 510(k) and include a copy of the Medical Device User Fee Cover Sheet with your submission.
  4.  Complete the Medical Device User Fee Cover Sheet

You should complete the Medical Device User Fee Cover Sheet (Form FDA-3601). The Medical Device User Fee Cover Sheet and instructions are available online.

You will need to register to create a Medical Device User Fee Cover Sheet. Please note that the User Fee Cover Sheet website was enhanced on March 1, 2005. Even if you have registered in the User Fee Cover Sheet system previously to March 1, 2005, you will need to follow the instructions as a “New User.”

You will need one of the following pieces of information to complete the registration process.

Organization #: 123456
Dun and Bradstreet Number (DUNS) # 123456789
Employer Identification Number (EIN) #  123456789

Additionally, you will need to identify a Principal Point of Contact (PPOC) in your organization who will be responsible for validating users for security purposes.

After you have registered and have created a user name and password, you will receive a confirmation email. You may then access the cover sheet creation page. A unique user fee Payment Identification Number will be generated on your cover sheet upon completion. You will need three copies of your completed User Fee Cover Sheet: one copy for your payment, one copy for your 510(k) submission, and one copy for your records.

Frequently Asked Questions addresses common questions regarding the Medical Device User Fee Cover Sheet.

Submit Your Payment

Send a printed copy of your User Fee Cover Sheet with your payment. Be sure to include the Payment Identification Number (beginning with MD) and the FDA P.O. Box on your check, bank draft, or U.S. Postal Money Order. The review fee may be submitted by mail, courier, or wire transfer.

Send your payment to:

By Mail:
Food and Drug Administration
P.O. Box 956733
St. Louis, MO 63195-6733By Courier: If the check is sent by a courier, the courier may deliver the checks to:
US Bank
Attn: Government Lockbox 956733
1005 Convention Plaza
St. Louis, MO 63101
(Note: This address is for courier delivery only. Contact the US Bank at (314) 418-4821 if you have any questions concerning courier delivery.)

By Wire Transfer:

“As of 1/31/10 US Bank will no longer accept Wire Transfers”
Wire transfers are now processed through the Federal Reserve Bank of New York. You will need the following information to remit a payment:

FDA Deposit Account Number: 75060099
US Department of Treasury Routing/Transit Number or ABA: 021030004
Federal Reserve Bank of New York
33 Liberty Street
New York, NY 10045
Tel (212) 720-5000
Also include your User Fee Payment Identification Number from your Medical Device User Fee Cover sheet when you send payment by wire transfer.Note: Your bank or financial institution may assess a fee for sending a wire transfer.
If needed for accounting purposes, FDA’s tax identification number is 53-0196965.
Fees should arrive at the bank at least 1 day before the application arrives at FDA. FDA recommends that you send the payment to the bank 4-5 business days before the application arrives at FDA so there is no delay in starting the review of your application. FDA records as the submission receipt date the latter of the following:1. The date the submission was received by FDA; or
2. The date Bank notifies FDA that payment has been received.
Bank is required to notify FDA within 1-working day, using the Payment Identification Number.

 Qualification for Small Business Fees

In FY2012 (October 1, 2011 through September 30, 2012), firms with annual gross sales and revenues with $100 million or less, including gross sales and revenues of all affiliates, partners, and parent firms, may qualify for lower rates for Premarket Notification 510(k) submissions.

An affiliate is defined by §737(8) of the FD&C Act: An affiliate means a business entity that has a relationship with a second business entity if, directly or indirectly,

  1. one business entity controls, or has the power to control, the other business entity; or
  2. a third party controls, or has power to control, both of the business entities.


To qualify, you must submit the MDUFMA Small Business Qualification Certification (Form FDA 3602). In addition, certified copies of your firm’s Federal Income Tax Return for the most recent taxable year, including certified copies of the income tax returns of all affiliates, partners, and parent firms must be provided.

The following guidance and form should be used.

FY2012 MDUFMA Small Business Qualification Worksheet and Certification

The Certification should be sent to:

MDUFMA Small Business Qualification
Division of Small Manufacturers, International and Consumer Assistance (DSMICA)
10903 New Hampshire Avenue, WO66-4613
Silver Spring, MD 20993

FDA will review the Certification within 60 days and send its decision that the firm is, or is not, a small business eligible for reduced or waived fees. If your firm qualifies as a small business, the decision letter will include a Small Business Decision number. The Small Business Decision number is used on the Medical Device User Fee Cover Sheet (Form FDA 3601) to demonstrate that your firm is entitled to a reduced fee. If you submit a reduced fee to FDA without a Small Business Decision number, the submission will not be accepted for filing.

The small business status expires at the end of each fiscal year (September 30th). A new MDUFMA Small Business Qualification Certification must be submitted each year to qualify as a small business.

Questions concerning Small Business Qualification should be directed to Division of Small Manufacturers, International and Consumer Assistance (DSMICA) at 301-796-7100 (800-638-2041).


(Source: www.FDA.gov)


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What to Do if You Can’t Find a Sharps Disposal Container?

Posted on May 30, 2012. Filed under: Syringe Blog | Tags: , , , , , , , , , , |

I Can’t Find a Sharps Container!


The safest way to dispose of a used needle is to immediately place it in a sharps disposal container to reduce the risk of needle sticks, cuts and punctures from loose sharps. If you cannot find a sharps disposal container right away, you may need to recap the needle or use a needle clipper until you have an opportunity to dispose of sharps in an appropriate sharps disposal container. Never throw away loose needles and other sharps in trash cans or recycling bins, and never flush them down the toilet. 



If you need to put the cap back on the needle (recap), do not bend or break the needle and never remove a hypodermic needle from the syringe by hand. This may result in accidental needle sticks, cuts or punctures. Recapping should be performed using a mechanical device or the one-handed technique (see below for step-by-step instructions). Recapped needles should be placed in a disposal container at the next available opportunity.

The One-Handed Needle Recapping Method

Step 1: Place the cap on a flat surface like the table or counter with something firm to “push” the needle cap against
Step 2: Holding the syringe with the needle attached in one hand, slip the needle into the cap without using the other hand
Step 3: Push the capped needle against a firm object to “seat” the cap onto the needle firmly using only one hand.


Needle Clippers


Needle clippers make syringes unusable by clipping off the needle. Clippers may be used for needle disposal of small syringes (such as insulin syringes), but not for clipping lancets.
After the needle clipper clips off the needle from the syringe, the needle is automatically and safely retained within the clipper.
Do not attempt to clip a needle with any tool except a needle clipper designed to safely clip a needle.

Before using any of the above procedures, check your community guidelines for acceptable sharps disposal methods.

Source ~ www.FDA.org

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Medical Device Fellowship Program

Posted on May 27, 2012. Filed under: Syringe Blog | Tags: , , , , , , , , , , , , , , , , , , , , , , , , , |

Medical Device Fellowship Program




The Center for Devices and Radiological Health (CDRH) Medical Device Fellowship Program (MDFP) provides opportunities for health professionals to participate in the FDA regulatory process for medical devices. MDFP is part of External Expertise and Partnerships (EEP) in the Office of the Center Director (OCD) in CDRH.  In addition to MDFP, other components of EEP include Technology Transfer and Partnerships, and the Critical Path Initiative.

CDRH regulates a wide array of medical devices and is involved with the latest medical device cutting-edge technology areas such as genomics, proteomics, diagnostics for personalized medicine, percutaneous heart valves, artificial hearts, tissue engineered wound dressing with cells, and bone void fillers with growth factors, and many others.

To keep pace with the rapid development of new technology, and to make decisions based on the best scientific information and knowledge available, CDRH routinely consults with experts in the academic community, other government entities, clinical practice, and the military. By filling gaps in expertise for a finite period of time, EEP enhances the efficiency and effectiveness of CDRH operations. EEP is the focal point of all CDRH fellowships and interorganizational partnerships. EEP also fosters scientific innovation by helping offices form partnerships with academia, private sector organizations, and government agencies.

CDRH established MDFP to increase the range and depth of collaborations between CDRH and the outside scientific community. The MDFP offers short and long-term fellowship opportunities for individuals interested in learning about the regulatory process and sharing their knowledge and experience with medical devices from the relatively simple to the highly complex.

Physicians with clinical or surgical expertise, engineers in biomedical, mechanical, electrical and software areas, and individuals from many other scientific disciplines have participated in the fellowship program. Opportunities are available for students in many areas as well.

Career Development

Learn about the FDA approval process for medical devices:

  • medical device design
  • clinical trial design and data
  • safety and efficacy evaluation
  • materials, performance, bioeffects and standards
  • adverse events


Public Service

  • Join CDRH’s mission to protect the public health by ensuring that medical devices are safe and effective
  • Share your expertise on complex device issues
  • Make a difference in the lives of patients and consumers



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How to Report a Medical Device Problem

Posted on May 24, 2012. Filed under: Syringe Blog | Tags: , , , , , , , , , , , , , , |

How to Report a Medical Device Problem

What is Medical Device Reporting (MDR)?

Medical Device Reporting (MDR) is the mechanism for the Food and Drug Administration to receive significant medical device adverse events from manufacturers, importers and user facilities, so they can be detected and corrected quickly. If you are a consumer or health professional you should use the nearby link to the MedWatch program for reporting significant adverse events or product problems with medical products.

User Facilities and MDR

User Facilities (e.g., hospitals, nursing homes) are required to report suspected medical device related deaths to both the FDA and the manufacturers. User facilities report medical device related serious injuries only to the manufacturer. If the medical device manufacturer is unknown, the serious injury is reported by the facility to FDA. Health professionals within a user-facility should familiarize themselves with their institution procedures for reporting adverse events to the FDA.
There is a guidance for user facilities, “Medical Device Reporting for User Facilities”.  See its nearby link.
Note: Please do not send the actual device to FDA as stated in Block D9 of the MEDWATCH 3500A form. In Block D9 indicate that you are keeping the device or returning it to the manufacturer.

History of MDR Regulation

Legislation requiring device user facility reporting was enacted by Congress to increase the amount of information the Food and Drug Administration (FDA) and device manufacturers receive about problems with medical devices. Although manufacturers and importers of medical devices have been required since 1984 to report to FDA all device-related deaths, serious injuries, and certain malfunctions, numerous reports have shown there is widespread underreporting. A 1986 General Accounting Office (GAO) study showed that less than one percent of device problems occurring in hospitals are reported to FDA, and the more serious the problem with a device, the less likely it was to be reported. A GAO followup study in 1989 concluded that despite full implementation of the Medical Device Reporting (MDR) regulation, serious shortcomings still existed.

Under the Safe Medical Devices Act of 1990 (SMDA), device user facilities must report device-related deaths to the FDA and the manufacturer, if known. Device user facilities must also report device-related serious injuries to the manufacturer, or to the FDA if the manufacturer is not known. In addition, SMDA also required that device user facilities submit to FDA, on a semiannual basis, a summary of all reports submitted during that time period. The device user facility reporting section of SMDA became effective on November 28, 1991.

To implement SMDA, FDA published a tentative final rule in the Federal Register on November 26, 1991, and invited comments on the regulation. Over 300 comments were received by FDA. Then, on June 16, 1992, the President signed into law the Medical Devices Amendments of 1992 (Public Law 102-300; the Amendments of 1992), amending certain provisions (section 519 of the Food, Drug, and Cosmetic Act) relating to reporting of adverse events. The primary impact of the 1992 Amendments on device user facility reporting was to clarify certain terms and to establish a single reporting standard for device user facilities, manufacturers, importers, and distributors. A final rule published in the Federal Register on December 11, 1995, addresses the comments received by the FDA and the changes mandated by the Amendments of 1992.

Update on FDAMA

The Food and Drug Administration Modernization Act (FDAMA) was signed on 11/21/97 and became effective on 2/19/98. There were four changes that affected MDR:

  • Manufacturers and distributors/importers do not need to submit annual certification.
  • Domestic distributors are no longer required to file MDR reports, but must continue to maintain complaint files. [Importers (initial distributors for devices manufactured overseas and imported into the USA) must continue to file MDR reports.]
  • User facilities must now file an annual report instead of semiannual reports to summarize their adverse event reports.
  • Sentinel reporting by user facilities was proposed.
    The MDR regulation was revised on 1/26/2000 and 5/8/2000 to incorporate the changes under FDAMA

See the nearby link to amendments to the MDR regulation that implemented FDAMA changes, effective March 27, 2000.




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What Is A Medical Device?

Posted on May 21, 2012. Filed under: Syringe Blog | Tags: , , , , , , , , , , , , , , , , , |

A medical device is an instrument, apparatus, implant, in vitro reagent, or other similar or related article, which is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, or intended to affect the structure or any function of the body and which does not achieve any of its primary intended purposes through chemical action within or on the body.[1] Whereas medicinal products (also called pharmaceuticals) achieve their principal action by pharmacological, metabolic or immunological means, medical devices act by other means like physical, mechanical, thermal, physico-chemical or chemical means.

Medical devices include a wide range of products varying in complexity and application. Examples include tongue depressors, medical thermometers, and blood sugar meters.

The global market of medical devices reached roughly 209 billion US Dollar in 2006 and is expected to grow with an average annual rate of 6–9% through 2010.[2]


European Union legal framework and definition

Based on the “New Approach”, rules relating to the safety and performance of medical devices were harmonised in the EU in the 1990s. The “New Approach”, defined in a European Council Resolution of May 1985, represents an innovative way of technical harmonisation. It aims to remove technical barriers to trade and dispel the consequent uncertainty for economic operators allowing for the free movement of goods inside the EU.

The core legal framework consists of 3 directives:

  • Directive 90/385/EEC regarding active implantable medical devices;
  • Directive 93/42/EEC regarding medical devices;
  • Directive 98/79/EC regarding in vitro diagnostic medical devices.

They aim at ensuring a high level of protection of human health and safety and the good functioning of the Single Market. These 3 main directives have been supplemented over time by several modifying and implementing directives, including the last technical revision brought about by Directive 2007/47 EC.

Directive 2007/47/ec defines a medical device as: “any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings. Devices are to be used for the purpose of:

  • Diagnosis, prevention, monitoring, treatment or alleviation of disease.
  • Diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap.
  • Investigation, replacement or modification of the anatomy or of a physiological process
  • Control of conception

This includes devices that do not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means.”

The government of each Member State is required to appoint a Competent Authority responsible for medical devices. The Competent Authority (CA) is a body with authority to act on behalf of the government of the Member State to ensure that the requirements of the Medical Device Directives are transposed into National Law and are applied. The Competent Authority reports to the Minister of Health in the Member State. • The Competent Authority in one Member State does not have jurisdiction in any other Member State, but they do exchange information and try to reach common positions.

In UK the Medicines and Healthcare products Regulatory Agency (MHRA) acts as a CA, in Italy it is the Ministero Salute (Ministry of Health)[3]

Medical devices must not be mistaken with medicinal products. In the EU, all medical devices must be identified with the CE mark.

Definition in USA by the Food and Drug Administration

Medical machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory that is:

  • recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,
  • intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment or prevention of disease, in man or other animals, or
  • intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes.

>>> Medical Device Definition US FDA <<<

Definition in Canada by the Food and Drugs Act

The term medical devices, as defined in the Food and Drugs Act, covers a wide range of health or medical instruments used in the treatment, mitigation, diagnosis or prevention of a disease or abnormal physical condition. Health Canada reviews medical devices to assess their safety, effectiveness and quality before being authorized for sale in Canada[citation needed].


The regulatory authorities recognize different classes of medical devices, based on their design complexity, their use characteristics, and their potential for harm if misused. Each country or region defines these categories in different ways. The authorities also recognize that some devices are provided in combination with drugs, and regulation of these combination products takes this factor into consideration.


The Medical Devices Bureau of Health Canada has recognized four classes of medical devices based on the level of control necessary to assure the safety and effectiveness of the device. Class I devices present the lowest potential risk and do not require a licence. Class II devices require the manufacturer’s declaration of device safety and effectiveness, whereas Class III and IV devices present a greater potential risk and are subject to in-depth scrutiny.[4] A guidance document for device classification is published by Health Canada .[5]

Canadian classes of medical devices generally correspond to the European Council Directive 93/42/EEC (MDD) devices as follows: Class IV (Canada) generally corresponds to Class III (ECD), Class III (Canada) generally corresponds to Class IIb (ECD), Class II (Canada) generally corresponds to Class IIa (ECD), and Class I (Canada) generally corresponds to Class I (ECD) .[6] Examples are surgical instruments (Class I); contact lenses, ultrasound scanners (Class II); orthopedic implants, hemodialysis machines (Class III); and cardiac pacemakers (Class IV) .[7]

United States

The Food and Drug Administration has recognized three classes of medical devices based on the level of control necessary to assure the safety and effectiveness of the device.[8] The classification procedures are described in the Code of Federal Regulations, Title 21, part 860 (usually known as 21 CFR 860).[9]

Class I: General controls

Class I devices are subject to the least regulatory control. Class I devices are subject to “General Controls” as are Class II and Class III devices.[8][10][11] General controls include provisions that relate to adulteration; misbranding; device registration and listing; premarket notification; banned devices; notification, including repair, replacement, or refund; records and reports; restricted devices; and good manufacturing practices.[11] Class I devices are not intended for use in supporting or sustaining life or to be of substantial importance in preventing impairment to human health, and they may not present a potential unreasonable risk of illness or injury.[11] Most Class I devices are exempt from the premarket notification and/or good manufacturing practices regulation.[8][10][11] Examples of Class I devices include elastic bandages, examination gloves, and hand-held surgical instruments.[10]

Class II: General controls with special controls

Class II devices are those for which general controls alone are insufficient to assure safety and effectiveness, and existing methods are available to provide such assurances.[8][10] In addition to complying with general controls, Class II devices are also subject to special controls.[10] A few Class II devices are exempt from the premarket notification.[10] Special controls may include special labeling requirements, mandatory performance standards and postmarket surveillance.[10] Devices in Class II are held to a higher level of assurance than Class I devices, and are designed to perform as indicated without causing injury or harm to patient or user. Examples of Class II devices include powered wheelchairs, infusion pumps, and surgical drapes.[8][10]

Class III: General controls and premarket approval

A Class III device is one for which insufficient information exists to assure safety and effectiveness solely through the general or special controls sufficient for Class I or Class II devices.[8][10] Such a device needs premarket approval, a scientific review to ensure the device’s safety and effectiveness, in addition to the general controls of Class I.[8][10] Class III devices are usually those that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury.[10] Examples of Class III devices which currently require a premarket notification include implantable pacemaker, pulse generators, HIV diagnostic tests, automated external defibrillators, and endosseous implants.[10]

European Union (EU) and European Free Trade Association (EFTA)

The classification of medical devices in the European Union is outlined in Annex IX of the Council Directive 93/42/EEC. There are basically four classes, ranging from low risk to high risk.

  • Class I (including Is & Im)
  • Class IIa
  • Class IIb
  • Class III

The authorization of medical devices is guaranteed by a Declaration of Conformity. This declaration is issued by the manufacturer itself, but for products in Class Is, Im, IIa, IIb or III, it must be verified by a Certificate of Conformity issued by a Notified Body. A Notified Body is a public or private organisation that has been accredited to validate the compliance of the device to the European Directive. Medical devices that pertain to class I (on condition they do not need to be sterilised or are not used to measure a function) can be put on the market purely by self-certification.

The European classification depends on rules that involve the medical device’s duration of body contact, its invasive character, its use of an energy source, its effect on the central circulation or nervous system, its diagnostic impact or its incorporation of a medicinal product.

Certified medical devices should have the CE mark on the packaging, insert leaflets, etc.. These packagings should also show harmonised pictograms and EN standardised logos to indicate essential features such as instructions for use, expiry date, manufacturer, sterile, don’t reuse, etc.


The classification of medical devices in Australia is outlined in section 41BD of the Therapeutic Goods Act 1989 and Regulation 3.2 of the Therapeutic Goods Regulations 2002, under control of the Therapeutic Goods Administration. Similarly to the EU classification, they rank in several categories, by order of increasing risk and associated required level of control; various rules exist in the regulation which allow for the device’s category to be identified [12]

Medical Devices Categories in Australia
Classification Level of Risk
Class I Low
Class I – measuring or Class I – supplied sterile or class IIa Low – medium
Class IIb Medium – high
Class III High
Active implantable medical devices (AIMD) High

Radio-frequency identification

Medical devices incorporating RFID

In 2004, the FDA authorized marketing of two different types of medical devices that incorporate radio-frequency identification, or RFID. The first type is the SurgiChip tag, an external surgical marker that is intended to minimize the likelihood of wrong-site, wrong-procedure and wrong-patient surgeries. The tag consists of a label with passive transponder, along with a printer, an encoder and a RFID reader. The tag is labeled and encoded with the patient’s name and the details of the planned surgery, and then placed in the patient’s chart. On the day of surgery, the adhesive-backed tag is placed on the patient’s body near the surgical site. In the operating room the tag is scanned and the information is verified with the patient’s chart. Just before surgery, the tag is removed and placed back in the chart.

The second type of RFID medical device is the implantable radiofrequency transponder system for patient identification and health information. One example of this type of medical device is the VeriChip, which includes a passive implanted transponder, inserter and scanner. The chip stores a unique electronic identification code that can be used to access patient identification and corresponding health information in a database. The chip itself does not store health information or a patient’s name.[13]

Practical and information security considerations

Companies developing RFID-containing medical devices must consider product development issues common to other medical devices that come into contact with the body, are implanted in the body, or use computer software. For example, as part of product development, a company must implement controls and conduct testing on issues such as product performance, sterility, adverse tissue reactions, migration of the implanted transponder, electromagnetic interference, and software validation.

Medical devices that use RFID technology to store, access, and/or transfer patient information also raise significant issues regarding information security. The FDA defines “information security” as the process of preventing the modification, misuse or denial of use, or the unauthorized use of that information. At its core, this means ensuring the privacy of patient information.[13]

Four components of information security

The FDA has recommended that a company’s specifications for implantable RFID-containing medical devices address the following four components of information security: confidentiality, integrity, availability and accountability (CIAA).

  • Confidentiality means data and information are disclosed only to authorized persons, entities and processes at authorized times and in the authorized manner. This ensures that no unauthorized users have access to the information.
  • Integrity means data and information are accurate and complete, and the accuracy and completeness are preserved. This ensures that the information is correct and has not been improperly modified.
  • Availability means data, information and information systems are accessible and usable on a timely basis in the required manner. This ensures that the information will be available when needed.
  • Accountability is the application of identification and authentication to ensure that the prescribed access process is followed by an authorized user.

Although the FDA made these recommendations in the context of implantable RFID-containing medical devices, these principles are relevant to all uses of RFID in connection with pharmaceuticals and medical devices.[13]

Medical devices and technological security issues

Medical devices such as pacemakers, insulin pumps, operating room monitors, defibrillators, surgical instruments including deep-brain stimulators are being made with the ability to transmit vital health information from a patient’s body to doctors and other professionals.[14] Some of these devices can be remotely controlled by medical professionals. There has been concern about privacy and security issues around human error and technical glitches with this technology. While only a few studies have been done on the susceptibility of medical devices to hacking, there is a risk.[15] In 2008, computer scientists proved that pacemakers and defibrillators can be hacked wirelessly through the use of radio hardware, an antenna and a personal computer[16] These researchers showed that they could shut down a combination heart defibrillator and pacemaker and reprogram it to deliver potentially lethal shocks or run out its battery. Jay Radcliff, a security researcher interested in the security of medical devices, raises fears about the safety of these devices. He shared his concerns at the Black Hat security conference.[17] Radcliff fears that the devices are vulnerable and has found that a lethal attack is possible against those with insulin pumps and glucose monitors. Some medical device makers downplay the threat from such attacks and argue that the demonstrated attacks have been performed by skilled security researchers and are unlikely to occur in the real world. At the same time, other makers have asked software security experts to investigate the safety of their devices.[18] As recently as June 2011, security experts showed that by using readily available hardware and a user manual, a scientist could both tap into the information on the system of a wireless insulin pump in combination with a glucose monitor. With a PIN access code of the device, the scientist could wirelessly control the dosage of the insulin.[19] Anand Raghunathan, a researcher in this study explains that medical devices are getting smaller and lighter so that they can be easily worn. The downside is that additional security features would put an extra strain on the battery and size and drive up prices. Dr. William Maisel offered some thoughts on the motivation to engage in this activity. Motivation to do this hacking might include acquisition of private information for financial gain or competitive advantage; damage to a device manufacturer’s reputation; sabotage; intent to inflict financial or personal injury or just satisfaction for the attacker.[20] Researchers suggest a few safeguards. One would be to use rolling codes. Another solution is to use a technology called “body-coupled communication” that uses the human skin as a wave guide for wireless communication.[19]

Standardization and regulatory concerns

The ISO standards for medical devices are covered by ICS 11.100.20 and 11.040.01.[21][22] The quality and risk management regarding the topic for regulatory purposes is convened by ISO 13485 and ISO 14971. ISO 13485:2003 is applicable to all providers and manufacturers of medical devices, components, contract services and distributors of medical devices. The standard is the basis for regulatory compliance in local markets, and most export markets.[23][24][25] Further standards are IEC 60601-1, for electrical devices (mains-powered as well as battery powered) and IEC 62304 for medical software. The US FDA also published a series of guidances for industry regarding this topic against 21 CFR 820 Subchapter H—Medical Devices.[26]

Starting in the late 1980s [27] the FDA increased its involvement in reviewing the development of medical device software. The precipitant for change was a radiation therapy device (Therac-25) that overdosed patients because of software coding errors.[28] FDA is now focused on regulatory oversight on medical device software development process and system-level testing.[29]

A 2011 study by Dr. Diana Zuckerman and Paul Brown of the National Research Center for Women and Families, and Dr. Steven Nissen of the Cleveland Clinic, published in the Archives of Internal Medicine, showed that most medical devices recalled in the last five years for “serious health problems or death” had been previously approved by the FDA using the less stringent, and cheaper, 510(k) process. In a few cases the devices had been deemed so low-risk that they did not need FDA regulation. Of the 113 devices recalled, 35 were for cardiovacular issues.[30] This may lead to a reevaluation of FDA procedures and better oversight.

Packaging standards

Medical device packaging is highly regulated. Often medical devices and products are sterilized in the package.[31] The sterility must be maintained throughout distribution to allow immediate use by physicians. A series of special packaging tests is used to measure the ability of the package to maintain sterility. Relevant standards include: ASTM D1585 – Guide for Integrity Testing of Porous Medical Packages, ASTM F2097 – Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products, EN 868 Packaging materials and systems for medical devices which are to be sterilized. General requirements and test methods, ISO 11607 Packaging for terminally sterilized medical devices, and others.

Package testing needs to conducted and documented to ensure that packages meet regulations and all end-use requirements. Manufacturing processes need to be controlled and validated to ensure consistent performance.[32][33]

Cleanliness standards

The cleanliness of medical devices has come under greater scrutiny since 2000, when Sulzer Orthopedics recalled several thousand metal hip implants that contained a manufacturing residue.[34] Based on this event, ASTM established a new task group (F04.15.17) for established test methods, guidance documents, and other standards to address cleanliness of medical devices. This task group has issued two standards for permanent implants to date: 1. ASTM F2459: Standard test method for extracting residue from metallic medical components and quantifying via gravimetric analysis[35] 2. ASTM F2847: Standard Practice for Reporting and Assessment of Residues on Single Use Implants[36]

In addition, the cleanliness of re-usable devices has led to a series of standards, including the following: 1. ASTM E2314: Standard Test Method for Determination of Effectiveness of Cleaning Processes for Reusable Medical Instruments Using a Microbiologic Method (Simulated Use Test)[37] 2. ASTM D7225: Standard Guide for Blood Cleaning Efficiency of Detergents and Washer-Disinfectors.[38]

The ASTM F04.15.17 task group is working on several new standards involving designing implants for cleaning, validation of cleanlines, and recipes for test soils to establish cleaning efficacy.[39] Additionally, the FDA is establishing new guidelines for reprocessing reusable medical devices, such as orthoscopic shavers, endoscopes, and suction tubes.[40]

Academic resources

  • Medical & Biological Engineering & Computing
  • Expert Review of Medical Devices
  • Journal of Clinical Engineering [41]

A number of specialist University-based research institutes have been established such as the Medical Devices Center (MDC) at the University of Minnesota in the US, the Strathclyde Institute Of Medical Devices (SIMD) at the University of Strathclyde in Scotland and the Medical Device Research Institute (MDRI) at Flinders University in Australia.

Source ~ Wikipedia

See also

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Posted on May 18, 2012. Filed under: Syringe Blog | Tags: , , , , , , , , , , , , , , , , , |


Group purchasing organizations (GPOs) play an important role in the provision of health care services in the United States. As hospitals and other health care providers have come under pressure to reduce expenses, they have turned increasingly to GPOs to reduce the costs of the products and services they purchase. Today, virtually every hospital in the U.S. belongs to at least one GPO. More than seventy percent of all hospital purchases are made through GPO contracts, and GPOs contract for purchases with an annual value in the range of $150 billion.

The fundamental purpose of a GPO is to allow its members to join together to leverage their purchasing strength in order to purchase goods and services at lower prices, which in turn should enable them to lower their costs and become more competitive in the provision of their own services. In its basic form, a GPO is a cooperative of buyers. Over time, however, GPOs have evolved significantly to offer other competition-enhancing programs such as networking, bench marking, and educational quality improvement programs. These functions are pro-competitive and consistent with antitrust policy – they offer GPO members increased efficiency, eliminate wasteful administrative duplication, and they increase competition between manufacturers/vendors, and within the hospital members’ own markets, which translate into lower prices and higher quality for consumers.

At a time when increasing health care costs are a major policy concern, one would expect GPOs to be seen as a major force in the health care industry for increased efficiency and cost containment. In fact, GPOs currently are under attack from several different directions. On the political front, GPOs have come under attack by some manufacturers of medical devices that claim GPO contracting practices, including “sole-source contracts,” percentage of purchase or “market share” discounts, and multi-product or “bundled” discounts, favor large established manufacturers with the result that smaller companies with “innovative” products are effectively foreclosed from selling to a large number of the nation’s hospitals. These concerns have attracted the attention of the U.S. Senate, which held hearings last year scrutinizing GPO contracting practices; the Senate may hold additional hearings on GPOs in 2003. Similarly, the Federal Trade Commission (FTC) held a workshop last fall at which GPO contracting practices were a topic of discussion, and the FTC, together with the Antitrust Division of the Department of Justice (DOJ), are holding health care hearings in 2003 at which GPO contracting practices also are being discussed. Finally, a 2002 preliminary study by the General Accounting Office (GAO) raised questions about whether GPO contracts actually save hospitals money.  GPO contracts also have been the subject of recent private litigation. In Kinetic Concepts, Inc. v. Hillenbrand Indus., Inc., a jury awarded more than $500 million in treble damages against a manufacturer of hospital beds that allegedly was using GPO contracts to exclude plaintiff, its competitor. In a suit more directly implicating GPO practices, Retractable Technologies, Inc. v. Becton Dickinson, et al., a manufacturer of safety syringes sued the two largest manufacturers of standard and safety syringes along with the two largest GPOs, alleging, among other things, a conspiracy between the GPOs and manufacturers to monopolize the needle and syringe market.

The important role GPOs play in the delivery of health care services, and the criticism that has been directed at them, raise important issues under the antitrust laws. Are GPOs the agents of efficiency they claim to be, or, as their critics charge, have GPOs become a vehicle for dominant manufacturers to achieve and/or maintain monopoly power? This article analyzes GPO contracting practices under the antitrust laws and whether these practices are likely to result in anti-competitive effects. As this analysis will show, in general, GPO contracts promote significant efficiencies and are unlikely to result in sufficient market foreclosure to injure competition. The policy implications of this conclusion are clear: instead of increasing competition, restrictions on GPO contracting practices are likely to result in less competition and higher prices for health care consumers.

I. History and Background of Group Purchasing Organizations Hospital GPOs trace their history back to the late 1800s, though the first known hospital GPO was the Hospital Bureau of New York, which appeared in 1910.  Over the next half century, the GPO concept grew slowly and by the early 1970s there were forty hospital GPOs in the United States. The next thirty years witnessed an explosion of GPOs. From 1974 to 1999,the number of GPOs grew from forty to 633.  Today, there are over 900 GPOs in the United States. While some of these are “child” GPOs that rely on contracts negotiated by larger “parent” GPOs, it is estimated that approximately 200 GPOs contract directly with suppliers, and that twenty-six of these operate on a national level.

It is not a coincidence that GPOs began to grow in popularity in the late 1970s and early 1980s. During this time, for-profit hospital chains began to expand and buy up not-for-profit hospitals, forcing not-for-profits to find ways to cut costs to remain competitive. In the early 1980s, Medicare instituted the Prospective Payment System through which hospitals were reimbursed a fixed rate based on a defined service rather than the cost to the hospital of providing that service. At the same time, growing pressure in the private sector to reduce health care costs in the form of Health Maintenance Organizations (HMOs) and other types of managed care also reduced hospital reimbursement. These external market factors made it important for hospitals to control costs. Part of this effort included forming or joining a GPO to lower the cost of goods and services that the hospitals purchased.

CONTINUE TO FULL ARTICLE WITH REFERENCES : http://www.ftc.gov/ogc/healthcarehearings/docs/030926bloch.pdf

Robert E. Bloch, Esq.
Scott P. Perlman, Esq,
Jay S. Brown, Esq.*
1909 K Street, N.W.
Washington, D.C. 20006
(202) 263-3000



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FDA Agreement On Medical Device User Fees

Posted on May 16, 2012. Filed under: Syringe Blog | Tags: , , , , , , , , , |

FDA and industry reach agreement in principle on medical device user fees 

The FDA and representatives from the medical device industry have reached an agreement in principle on proposed recommendations for the third reauthorization of a medical device user fee program.

The recommendations would authorize the FDA to collect $595 million in user fees over five years, plus adjustments for inflation. Details of the agreement, such as the fee structure, are expected to be finalized soon.

Under a user fee program, industry agrees to pay fees to help fund a portion of the FDA’s device review activities while the FDA agrees to overall performance goals such as reviewing a certain percentage of applications within a particular time frame.

The agreement in principle is the result of over a year of negotiations between the FDA and industry. It strikes a careful balance between what industry agreed to pay and what the FDA can accomplish with the amount of funding proposed. It would result in greater accountability, predictability, and transparency through such improvements as a more structured pre-submission process and earlier interactions between FDA and applicants.  With the additional funding, the FDA would be able to hire over 200 full-time equivalent workers by the end of the five-year program. The FDA and industry expect that the agreement in principle would result in a reduction in average total review times.

“I want to commend my staff and representatives from industry for their tireless work and commitment to achieving an agreement in principle on medical device user fees,” said FDA Commissioner Margaret A. Hamburg, M.D.  “Reauthorization of this important program is an essential component for advancing medical device innovation.”

The industry associations who have reached an agreement in principle with the FDA include the Advanced Medical Technology Association, the Medical Device Manufacturers Association and the Medical Imaging and Technology Alliance.

Congress first established the user fee program 10 years ago with the Medical Device User Fee and Modernization Act of 2002 (MDUFA I), prompted by growing concerns about the capacity and performance of the medical device review program. The five-year program was reauthorized with the Medical Device User Fee Act of 2007 (MDUFA II) and is set to expire on Sept. 30

MDUFA II authorized FDA to collect user fees for certain medical device applications, for the registration of certain medical device establishments, and for certain other purposes. Small businesses may qualify for a waiver from fees on certain submissions or may qualify for a reduced fee.

In September 2010, prior to beginning negotiations with regulated industry, the FDA held a public meeting on the device user fee program attended by a variety of stakeholders including industry, scientific and academic experts, health care professionals, and representatives from patient and consumer advocacy groups. Stakeholders provided their assessment of the overall performance of the MDUFA program and their opinions about which aspects of the program should be retained, changed, or discontinued in order to further strengthen and improve the program.

Once the final details of the agreement with industry is completed, FDA will develop a package of proposed recommendations and give the public an opportunity to comment before they are submitted to Congress.

The date of the public meeting has yet to be determined.


For more information:

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.


For Immediate Release: Feb. 1, 2012

Media Inquiries: Karen Riley, 301-796-4674,


Consumer Inquiries: 888-INFO-FDA


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510(k) Myths vs. Facts

Posted on May 12, 2012. Filed under: Syringe Blog | Tags: , , , , , |

Myth #1:  Substantial equivalence involves showing that a new device is similar to an old and outdated product on the market before May 28, 1976.

Fact: This is perhaps the most common misunderstanding of the 510(k) program that results in unwarranted criticism. In reality, it is extremely unusual by today’s standards for a new device to go to market with a comparison to a 30-year-old device. The majority of today’s 510(k) clearances result from comparisons to today’s state-of-the-art technology. While it is true that Section 510(k) initially envisioned that products compared to a medical device on the market prior to enactment of the 1976 Medical Device Amendments could be marketed after being determined to be “substantially equivalent” SMDA amended the law to refer to comparisons to “legally marketed devices.” SMDA also established that a new device can not be found substantially equivalent to a device that has been deemed misbranded or adulterated and removed from the market. Additionally, FDAMA authorized FDA reliance on national and international consensus standards which usually reflect state-of-the-art test methods developed to assess the latest  in device technology. This evolution in the program, coupled with FDA’s authority to require virtually any data necessary for decision-making, has made the 510(k) program one of the most progressive premarket review programs in FDA. Perpetuating this notion that new devices are simply compared to older devices as a means to market does a considerable disservice to the 510(k) program and undermines the program’s true value and contribution to the protection of the public health.

Myth #2:  The 510(k) program is a “quick and easy” way for manufacturers to get their product into the market.

Fact: The 510(k) program has been designed to provide a flexible means to appropriately regulate a wide variety of medical devices, and places appropriate regulatory requirements where necessary. Contrary to what some detractors espouse, today’s 510(k) program is anything but a “quick and easy” way to market. While 510(k)s for the simplest of devices (e.g., syringes) may experience a streamlined evaluation, consuming less than 90 days of FDA review, any greater degree of regulatory burden would represent a waste of FDA resources with little to no public health benefit. Likewise, modifications to legally marketed devices may be eligible for a review of less than 90 days, but again, the rigor of FDA’s evaluation matches the potential impact of the modification on the safety and effectiveness of the device and relies heavily on the design control provisions of the Quality System Regulation (QSR). For devices that represent significant changes in intended use or involve changes in technology, it is not uncommon for review times to exceed 90 days and require several rounds of FDA review. From a perspective of difficulty and scientific rigor, simple devices may go to market based on a comparison of specifications, but as a device’s public health significance, technological complexity or risk increases, so does the scientific demands imposed by FDA’s reviews. Today, it is common for 510(k) submissions to be based on batteries of non-clinical tests, including testing against national and international consensus standards. Further, it is not uncommon for FDA to require clinical evidence to support certain decisions where this level of scientific rigor is warranted. The necessity for clinical evidence is not solely dependent on the class of the device but is instead derived from the risk analysis that is conducted as part of the design validation aspect of design controls. Manufacturers of class II and class III devices are responsible for complying with design control requirements under the Quality System Regulation. They are therefore responsible for conducting a risk analysis and determining the amount of supporting data, preclinical and clinical, necessary for the premarket submission and maintaining it in the design history file for FDA inspection. The bottom line is that there are instances where the demands of today’s 510(k) review process becomes a barrier to market entry that some companies do not have the ability or financial resources to overcome.

Myth #3:  Device malfunctions and patient injuries result from devices undergoing 510(k) review and serve as evidence that all devices should undergo the rigors of premarket approval to ensure their safety and effectiveness.

Fact: There are many reasons why critics of the 510(k) program argue that all devices should receive premarket approval. Device malfunctions that result in patient injury and device failures discovered in the postmarket period are frequently cited in support of the argument that all medical devices should follow the PMA process. One oft-cited example of a presumed “failure” of the 510(k) process is the Vitek TMJ implant. Five years after clearance of the device, FDA became aware of complaints of injuries attributed to the deterioration of the device material. Subsequently, FDA issued a letter citing good manufacturing practices (“GMP”) and medical device reporting (“MDR”) violations. Based on this unfortunate experience, it has been inferred that had the device been regulated through the more rigorous PMA program, the failures would not have occurred. This line of thinking is simply flawed. Manufacturing problems can only be addressed through robust quality systems, not paper reviews that are conducted at FDA headquarters. Likewise, clinical evaluation in the premarket period cannot identify or predict all problems that may occur when a device is made commercially available and placed in widespread distribution.  Further, the long-term effects of devices will never be fully identified and problems eliminated by clinical evaluation in the premarket period, whether the FDA review is through the PMA or 510(k) processes. In essence, the experience cited by the program’s critics is independent of the pathway to market.
Most importantly, the 510(k) program is only one of many regulatory controls FDA has in place to ensure the safety and effectiveness of medical devices, regardless of their path to market. In addition to obtaining FDA authorization to market a new device, manufacturers must comply with the other general controls including good manufacturing practices through the Quality Systems Regulation and medical device reporting, as well as any special controls. Special controls may include performance standards, guidance documents, post-market surveillance, device tracking, and other activities needed to provide a reasonable assurance of safety and effectiveness.

Myth #4:  The Third Party Review Program that is available for select devices subject to 510(k) is an “easier” path to market that avoids FDA review.

Fact: Following enactment of FDAMA, FDA has accredited a number of independent third party review organizations to perform the premarket review of select class I and class II devices subject to 510(k) requirements. Like the 510(k) process, the “Accredited Persons Program” is misunderstood and misrepresented and has been a source of unfair criticism. While it is true that this program may speed up the review process, any increase in efficiency is largely attributable to the fact that the review commences immediately upon assignment and usually does not languish in a queue. The premarket review is not conducted by less qualified review scientists. Also, contrary to statements related to the program, including some made to Congress, FDA remains responsible for the final decision and the overall process is no less stringent than one conducted internally by FDA’s review scientists.

View AdvaMed 510 (k) Myths vs. Facts ~ PDF









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