The FDA announced in the Federal Register on March 19 that it will hold a public workshop on April 21 to discuss the assessment and management of risk in the use of medical devices. Entitled “Clinical Considerations of Risk in the Postmarket Environment,” the workshop is aimed at gaining input on dealing with medical device hazards that the agency did not identify during approval or clearance.

As explained in the Federal Register announcement, the agency’s reason for holding the workshop is that “when postmarket safety or quality issues arise … FDA and industry may base their decisions about postmarket quality and safety on different information.” The agency hopes that the workshop will help bridge those differences.

The workshop will include a draft list of risk principles and factors to consider in analyzing postmarket medical device risk. The agency developed the list in 2014 in collaboration with a working group of the Association for the Advancement of Medical Instrumentation (AAMI). The draft paper is available on the AAMI website.

In addition, FDA wants to discuss the following general questions:

  • What factors are important to take into account when conducting risk assessments of safety and quality issues that occur with marketed medical devices?
  • What principles best guide the risk assessment process to assure timely, consistent, and optimal results?
  • Are there improvements that FDA and stakeholders could make to enhance risk assessments in recall and shortage situations with medical devices?
  • Are there specific activities or issues related to postmarket quality, safety, or compliance activities where approaches used by FDA and industry currently differ enough to create confusion or delay or limit appropriate public health actions?
  • In which activities and areas of postmarket quality, compliance, and safety would more detailed policies or guidance be most useful?

The day-long workshop on medical device risk will be held on April 21, 2015, at FDA’s White Oak Campus in Silver Spring, Md. The event will be simultaneously Webcast. Registration for both formats closes at 4:00 pm on April 13, 2015. Early registration is recommended for both because space and webcast connections are limited. For more details, see the Federal Register notice.