• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services


  • Print
  • Share
  • E-mail

Conclusions, Recommendations, And Options (Part 3)

Table of Contents: Managing the Risks From Medical Product Use: Creating a Risk Management Framework

Previous Section : Other Efforts being considered to expand FDA's Postmarketing Risk Assessment

To summarize, FDA currently employs a variety of postmarketing surveillance and risk assessment programs to ensure the continued safe use of medical products. Despite their dependence on the other participants in the overall risk assessment system, FDA's programs have been able to identify new risks and assess their impacts. However, recent regulatory changes, an increasingly complex healthcare environment, and the emerging global marketplace all present challenges to the existing system. As a result, the Agency has initiated a number of efforts to expand its programs to meet these challenges, including increasing the quality of reports, creating global reporting standards, and implementing electronic safety reporting. Increased resources are needed to support these ongoing efforts. In addition, a number of other options are available that could help the Agency meet the changing needs of the current system for postmarketing surveillance and risk management if resources could be made available. The options discussed in this Part are summarized below.


We recommend the Agency take the following actions:

  • Rapidly complete the pharmaceutical products Adverse Event Reporting System (AERS), and correspondingly enhance the medical device Manufacturers and User Device Experience (MAUDE) system.
  • Integrate existing postmarketing information systems so analytic tools, data entry, and editing can be uniformly applied, and all information is readily available to every reviewer.
  • Enhance and intensify surveillance of newly marketed products.
  • Enhance clinical and laboratory studies to develop new methods to improve product safety.
  • Develop new methodological tools for inference from available datasets.

Additional options

Additional options to improve postmarketing surveillance could include the following:

  • Coordinate premarketing and postmarketing information to ensure full consideration of all available safety data at each stage of review.
  • Supplement existing reporting channels by establishing and supporting institutions to serve as sentinel sites for adverse event reporting. Such sites would produce a higher rate of event reports and more completely analyze each event, further enhancing the value of their reports.
  • Provide cross-agency access to external healthcare databases. This would allow the Agency to more quickly investigate signals generated by spontaneous reports and would be particularly valuable in determining the rate of adverse events.
  • Design, implement, and maintain prospective product use registries (the bulk of support should come from manufacturers).
  • Increase resources to conduct focused epidemiological studies when support of these studies by manufacturers is not feasible.
  • Conduct methodological research on the costs and value of various approaches to understanding adverse events among marketed products



1 Appendix B contains some examples of regulations, guidance, proposed rules, and International Conference on Harmonsation (ICH) documents on postmarketing surveillance.

2 Section 519(b)(5) of the FD&C Act (section 213 of the Modernization Act).

3 Section 506B of the FD&C Act (section 130 of the Modernization Act).

4 This proposed rule published in the Federal Register on September 23, 1997, 62 FR 49642.

5 FDA accesses these databases through IMS Health Products and Services. Services are accessed in a number of ways including direct rransfer from IMS's mainframe, through books, and using CD-ROM.

6 Angiotensin converting enzyme inhibitors.

7 Full implementation and consequent fiscal savings to the Agency will take a requirement for manufacturers to submit adverse event reports to the Agency elecronically.

Next Section : Part 4:Managing the Risks from Medical Product Use