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FDA > CDRH > Medical Device Postmarket Transformation Initiative > Postmarket Transformation Initiative, Qs & As – External Audience

Postmarket Transformation Initiative
Qs & As – External Audience

What is the list of recommendations for strengthening the medical device postmarket program?

The Report of the Center for Devices and Radiological Health’s (CDRH’s) Postmarket Transformation Leadership Team provided twenty-six recommendations in four categories (Create a Culture of Collaboration, Develop World Class Information Systems, Enhance Risk-Benefit Communication Efforts, and Focus Enforcement Strategies). These can be found on pages 13-23 of the report. Of these, the following nine were selected for immediate action:

  1. Create medical device cross-cutting collaborative product groups to better integrate premarket, postmarket and enforcement efforts. (Recommendation I.1)
     
  2. Develop methods and metrics for tracking and assessing progress in the Center’s performance in handling postmarket issues. (Recommendation II.A.1)
     
  3. Aggressively pursue the development of unique identifiers (UDI) for medical devices, in collaboration with industry and health care providers, in order to easily identify specific devices when postmarket questions are raised. (Recommendation II.C.1)
     
  4. Optimize the Center’s passive surveillance systems by making electronic reporting of adverse event data mandatory (“eMDR”). (Recommendation II.B.1)
     
  5. Make medical device reporting (MDR) and other postmarket data broadly available to staff by revising and updating the MAUDE system, and expanding the premarket data warehousing effort to include postmarket applications. (Recommendation II.A.2)
     
  6. Transform the quantity and quality of Center/Office of Regulatory Affairs (ORA) interactions through increased collaboration within CDRH and among CDRH, ORA and the Office of Chief Counsell (OCC). (Recommendation IV.2)
     
  7. Develop and implement a risk-communication strategy to maximize CDRH’s ability to communicate information in a clear and timely way to practitioners, patients and consumers (Recommendation III.1)
     
  8. Design a pilot project to test whether quantitative decision-making methods can be useful in regulating medical devices across the total product life cycle (Recommendation II.C.; see also Appendix E)
     
  9. Increase active surveillance by enhancing MedSun programs that reach out to participants and get answers to pressing public health questions (Recommendation II.B.4)

Why does the Center feel the need to move forward with this Postmarket Transformation?

The postmarket program has been a high priority in the Center for a number of years. Even though we have a rigorous review process for new devices before they are marketed, new safety concerns can arise after a product is in widespread use. Rare adverse effects that could not be detected during clinical trials may only become apparent after the device is used on large populations of patients, and the use of the device by an increasing number of physicians on more diverse patient groups may increase the number and variety of adverse effects. . The Center routinely receives and analyzes reports of adverse events associated with the use of medical devices, but this system needs to be more comprehensive and timely

Are regulatory modifications required to implement these recommendations?

The Center has no plans to request additional regulatory authorities in order to implement this initiative. We believe that the regulatory authority given to CDRH through our existing laws and regulations are adequate. The Center plans to maximize the use of these authorities and the enforcement tools that currently exist.

Does this mean that FDA will be collaborating more with professional societies?

Yes, the FDA will seek collaboration with key professional and technical societies to enhance our risk communication efforts, to share data and use information, and to enlist the expertise of the societies’ members.

Can FDA achieve the recommendations with existing resources?

The Center is presently defining the implementation needs for this transformation effort and anticipates that additional funding will be needed for specific projects and initiatives. Some projects are already underway and supported through appropriated funds. However, others will need substantial additional resources in order to begin or fully implement the projects.

How does FDA plan to implement changes?

The Center has taken the first steps of implementation by announcing the transformation initiative and informing stakeholders of the list of immediate actions to be taken. The report of the CDRH Postmarket Transformation Leadership Team provides a roadmap for the implementation. The next step is to convene implementation teams that will be charged with developing specific action plans to proceed with the nine immediate actions identified within the four recommendation categories.

When should we expect to see changes?

The Center hopes to have a more defined implementation plan for the matrix project groups early in 2007. Meanwhile, other changes are already occurring in CDRH. For example:

Updated November 9, 2006

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