Archive for June, 2012

What does it mean when FDA “clears” or “approves” a medical device?

Posted on June 10, 2012. Filed under: Syringe Blog | Tags: , , , , , , , , , , , , , , |

When FDA review is needed prior to marketing a medical device, FDA will either:



  1. “clear” the device after reviewing a premarket notification, otherwise known as a 510(k) (named for a section in the Food, Drug, and Cosmetic Act), that has been filed with FDA, or
  2. “approve” the device after reviewing a premarket approval (PMA) application that has been submitted to FDA.

Whether a 510(k) or a PMA application needs to be filed depends on the classification of the medical device.

To acquire clearance to market a device using the 510(k) pathway, the submitter of the 510(k) must show that the medical device is “substantially equivalent” to a device that is already legally marketed for the same use.

To acquire approval of a device through a PMA application, the PMA applicant must provide reasonable assurance of the device’s safety and effectiveness.



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Is A New 510k Required For A Modification To Your Medical Device?

Posted on June 6, 2012. Filed under: Syringe Blog | Tags: , , |

Is a new 510k required for a modification to the device? 



As described in 21 CFR 807.81(a)(3), a new complete 510(k) application is required for changes or modifications to an existing device, where the modifications could significantly affect the safety or effectiveness of the device, or the device is to be marketed for a new or different indication.
When a 510(k) holder decides to modify an existing device, the holder must decide whether the proposed device modification(s) requires submission of a 510(k). It is not FDA’s intent that a 510(k) must be submitted for every modification. However, all changes in indications for use require the submission of a 510(k). A change in indication for use includes prescription use to over the counter use. Deciding When to Submit a 510(k) for a Change to an Existing Device provides guidance to 510(k) holders on deciding when to submit a 510(k) for a change to an existing device.
Examples of modifications that may require a 510(k) submission include, but are not limited to, the following:
  • Sterilization method
  • Structural material
  • Manufacturing method
  • Operating parameters or conditions for use
  • Patient or user safety features
  • Sterile barrier packaging material
  • Stability or expiration claims
  • Design
FDA believes that the 510(k) holder is best qualified to determine when modifications to their device could significantly affect safety or effectiveness. Therefore, every modification to the device should be reviewed by appropriate personnel to determine if it affects safety or efficacy. Any design or labeling change to a device should be evaluated and documented in accordance with the 21 CFR 820, Quality System regulation. If it is determined that the modification is not significant, the basis for this decision should be documented with supporting data in the 510(k) holder’s device master file. If it is determined that the modification is significant, a new 510(k) must be submitted to FDA.
There are no provisions for a 510(k) amendment or supplement to the existing 510(k). A new 510(k) must be submitted. However, FDA developed a streamlined 510(k) process for modifications to a device cleared under 510(k), called the Special 510(k).

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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).



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How Human Factors Lead to Medical Device Adverse Events

Posted on June 1, 2012. Filed under: Syringe Blog | Tags: , , , , , , , , , , , , , , , , , |

Medical Device Adverse Events

By Suzanne Rich, RN, CT, MA                                                                                                                                              FOLLOW US ON TWITTER
ADVERSE EVENTS involving medical devices or equipment can lead to serious problems, including incorrect or delayed diagnosis and treatment or patient injuries. When errors involving medical devices recur repeatedly, people typically blame the users instead of the real culprit, which is often a poorly designed interface between the medical device and the user. Human factors is the science that focuses on understanding and supporting how people interact with technology.
In health care, the objective of human factors is to improve human performance with medical products, including medical devices, and to reduce the likelihood of error or injury, thus improving patient and workplace safety.1 In this article, I’ll discuss some common problems and steps you can take to prevent them.

Design considerations

The complexity and diversity of medical devices used simultaneously contribute to human factors errors. A key objective of human factors in medical device design is to enhance the likelihood of good performance under less-than-ideal conditions. To minimize human factors problems, devices should be designed according to users’ needs, abilities, limitations, and work environments. This includes the design of the device’s user interface, which includes controls, displays, software, labels, and instructions—anything the user may need to operate and maintain a device.
Good design should include:
  • operation that’s intuitive and doesn’t require frequent reference to an instruction manual
  • easy-to-read displays
  • easy-to-use controls
  • appropriate connections of device-to-device and device-to-outlet for safe use
  • effective alarms
  • easy repair and maintenance.2
Consider three major areas when evaluating medical-device-related adverse events from a human factors perspective:
  1. user characteristics, including the person’s abilities and training and her expectations of the device
  2. device design considerations, which focus on the device-user interface, including
    instructions for use
  3. the environment in which the device
    is used, including the lighting, noise,
    distractions, and time constraints.1 , 2
Let’s examine these elements in more detail, starting with the device user. For examples of errors in each major area, see Troubling human factors problems.

Training and expectations

Make sure everyone using a device has received training on it. Then consider a less obvious factor, the user’s expectations of how the device works. Whether a user is a health care professional or a patient, she may expect a device to work like another device that looks similar. For example, based on her experience, she may expect a device to deliver the same prescribed treatment or dose as a similar device, or expect the alarms to be in a specific sequence or pattern of sounds. Many reported I.V. fluid pump programming errors resulted when the actual device function wasn’t what the user expected.3

Looking at design

A user’s ability to interpret or understand device communication is often impaired by incomplete, confusing, or misleading labeling and instructions for use. Ambiguity about the sequence of steps required for device setup and operation can also be a factor.
Sometimes the instructions for use aren’t easily accessible, which prompts users to operate devices based on previous experience instead of on the requirements found in the labeling. An example of this problem is when the text or numeric font is difficult to find in the device’s display panel.
When similar devices are made by different manufacturers, the vocabulary in text displays may be inconsistent. For example, adverse events have involved devices that used different units of measure, such as cubic centimeters instead of milliliters. When devices display unfamiliar text abbreviations or words, this may further compound difficult or confusing navigation through menus to set up the device, leading to errors.
Make sure that when your facility chooses devices, it takes into account the following visual, auditory, and tactile features of the interface between user and device.

Visual considerations:


  • The user can see the device displays, labels, or markings.
  • Display screens are easy to see, have clear contrast, and are bright enough to be seen without glare.
  • The font is large enough to be read by all users.

Auditory considerations:


  • The user can easily hear and interpret alarms.
  • The sequence of sounds is appropriate in volume, frequency, tone, and pitch.
  • The alarm’s timing clearly defines the acuity of the warning and gives the user enough time to make adjustments and corrections.

Tactile considerations:


  • The device’s components can be connected easily.
  • The device’s components can’t be easily disconnected or connected by mistake. (Problems have been reported with some electrodes, cables, and I.V. tubing.)
  • The device’s components can be connected so that the user feels a “click” to help ensure a proper connection.
  • The user can feel the controls of knobs, buttons, switches, and keypads.
Instructions for maintaining and cleaning the device should be clear and include what compounds can and can’t be used. Some devices, such as electronic medical devices, shouldn’t be cleaned with fluids, which can leak into the device housing and cause performance problems and even fires. Some cleaning agents may degrade or otherwise affect a device’s plastic casings, impairing performance.

Consider the environment

Both user and device performance can be influenced by physical characteristics of the environment, such as adequate lighting, clear and unobstructed views of devices (especially those used for monitoring), and controls for temperature and humidity.
These workplace constraints can contribute to medical device errors or
adverse events:
  • staff with heavy workloads, such as multiple high-acuity patients
  • staff working double shifts
  • float and temporary staff who may be unfamiliar with the unit’s equipment
  • different brands or models of the same type of equipment within the same facility.
Some organizations have moved to using a single brand or model throughout their facilities.

Reporting problems

If an error or an adverse event occurs despite your best efforts, take action. Medical-device-related adverse events involving death or serious injury must be reported. Reporting near misses or events that could cause patient harm can help identify system improvements that can prevent similar adverse events in the future. Follow your facility’s policies and procedures. You can report events to MedWatch.  See the nearby link to MedWatch.
Addressing human factors in both the design and clinical use of medical devices mitigates risk, improves patient safety, and improves workplace safety.


Adverse events reported to the Food and Drug Administration involving human factors errors range from the simple to the complex. Here are examples of errors in each major area involving human factors:4
User expectations. One error involved an otoscope and transilluminator that look similar but have different light intensities. During an urgent intervention, the health care provider picked up an otoscope, thinking it was a transilluminator. When he tried to use it to locate a child’s vein for an I.V. catheter insertion, the patient experienced a second-degree burn.
Device design. Another error concerned noninvasive blood pressure (BP) tubing that was mistakenly connected to I.V. tubing. The patient, who was being monitored in the ED with a noninvasive automatic BP device, also had an I.V. catheter. The BP cuff tubing was disconnected when the patient went to the bathroom, and it was reconnected upon his return. The patient’s wife found the patient “blue from the neck up.” Despite resuscitation efforts, he died. The BP cuff tubing had been connected to the I.V. catheter and had delivered about 15 mL of air. An autopsy confirmed a fatal air embolus.5
Environment. A safety issue was reported when newly purchased ventilators were placed into service in a trauma ICU. Staff immediately noted that the ventilators had an alarm that wasn’t audible when the patient-room door was closed. Although the devices weren’t defective, they weren’t suited to the environment where they were being used.

1. FDA’s Human Factors Program: Promoting safety in medical device use. Accessed March
27, 2008.
2. Sawyer D. Do it by design: An introduction to human factors. Accessed March 27, 2008.
3. Rich S. Medical devices and patient safety: The role of human factors. Association for Vascular Access Pre-Conference, Indianapolis, Ind., September 8, 2006.
4. Food and Drug Administration. Manufacturer and User Facility Device Experience (MAUDE). Accessed March 27, 2008.
5. Eakle M, et al. Luer-lock misconnects can be deadly. Nursing2005. 35(9):73, September 2005.

Suzanne Rich is a senior project manager of the patient safety staff at the Office of Surveillance and Biometrics, Center for Devices and Radiological Health at the Food and Drug Administration in Rockville, Md. (Article reprinted from June Nursing2008, Volume 38, Number 6, Pages 62-63)

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