Medical Device Fellowship Program

Medical Device Fellowship Program (EEP, OCD, CDRH) 

Introduction 

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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 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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FDA Guidance On Approving Medical Devices

New 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.

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