On March 19, 2015, FDA published a public workshop notice entitled “An Interactive Discussion on the Clinical Considerations of Risk in the Postmarket Environment.” This meeting is being held on April 21 in order for FDA to further engage with the medical device industry on “assessing changes in medical device risk as quality and safety situations arise in the postmarket setting.” These risks may be novel risks that were not known at the time of FDA approval or clearance or they may be known risks that are occurring at an unexpected rate in the clinical setting or in unexpected populations or use environments.

FDA explains in the public workshop notice that when postmarket safety or quality issues arise, FDA and industry typically take different approaches in conducting risk analyses. FDA looks to information contained in the firm’s premarket submission as well as information collected at inspection. At the same time, industry analyzes changes from their “preproduction risk analysis to their postmarket experience.” As a result, FDA and industry may reach different conclusions on what constitutes appropriate actions.

Industry and CDRH started a conversation on developing a shared understanding on how to assess and manage postmarket risk in late 2014, when CDRH and the Association for the Advancement of Medical Instrumentation (AAMI) established a working group “to develop a draft list of risk principles and factors to consider in analyzing postmarket risk.” Based on the working group discussions, AAMI published a draft white paper in February 2015 that provides draft principles and factors for assessing unanticipated postmarket quality and safety issues. These draft principles and factors will be presented at the upcoming FDA public meeting. In addition, AAMI is seeking comment on this white paper until May 20, 2015.

FDA’s public meeting notice provides four questions that will be discussed at the public meeting.

  • 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? Please identify them.
  • In which activities and areas of postmarket quality, compliance, and safety would more detailed policies or guidance be most useful?

This postmarket risk discussion builds upon a series of CDRH efforts to bring more focus to postmarket controls. In 2013, CDRH released a report entitled “Strengthening Our National System for Medical Device Postmarket Surveillance: Updates and Next Steps.” The report updated the postmarket surveillance plan issued by CDRH in 2012 (see our blog post here). On April 23, 2014, FDA released a draft guidance “Balancing Premarket and Postmarket Data Collection for Devices Subject to Premarket Approval,” which discusses the role of postmarket information in FDA’s premarket review. Industry comments in connection with the public workshop and on the draft white paper can help to further these efforts.