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
———————-

www.QDSyringeSystems.com
www.Twitter.com/QDSyringe
www.Syringes.co

Advertisements
Read Full Post | Make a Comment ( None so far )

Medical Device Fellowship Program

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

Medical Device Fellowship Program

(EEP, OCD, CDRH) 

Introduction

 

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

———————-

www.QDSyringeSystems.com
www.Twitter.com/QDSyringe
www.Syringes.co

Read Full Post | Make a Comment ( None so far )

Liked it here?
Why not try sites on the blogroll...