On August 17, the industry comment period for the FDA’s Medical Device Safety Action Plan closed. Back in April of this year, the FDA announced the new Plan, which is directed at the public, companies, patients, and other stakeholders. The Plan outlines how the agency will help to encourage innovation in the Medical Device sector while maintaining and improving safety. This plan focuses on five key areas:
- To establish a robust medical device patient safety net in the US;
- To explore regulatory options to streamline and modernize timely implementation of postmarket mitigations;
- To spur innovation towards safer medical devices;
- To advance medical device cybersecurity; and
- To integrate CDRH’s premarket and postmarket offices and activities to advance the use of a Total Product Life Cycle (TPLC) approach to device safety.
New Initiatives for the Medical Device Safety Action Plan
While the Plan was posted in April, the FDA was accepting comments until August 17. Under this plan, many initiatives were mentioned:
- The CDRH is looking to reorganize the offices that will integrate CDRH’s premarket and postmarket offices across functions to allow for better implementation of a Total Product Life Cycle (TPLC) approach to device safety. The FDA is also considering an umbrella regulation that will cover many of the points in the action plan.
- Different steps that could be taken by the FDA to help drive innovation towards safer technologies (and encouraging manufacturers to make even iterative changes if they will lead to a reduction in patient risk) are being investigated and implemented. While this is admirable, it is important to note that safety is the number one priority for many manufacturers already in the industry. The Plan also suggests that FDA may explore actions that would provide more streamlined pathways for comparative safety claims. Because FDA is not typically involved in reviewing or approving comparative safety claims, it is unclear what kind of streamlined pathway is needed or how this will impact current practices.
- Another key point of the Action Plan is to advance cybersecurity through updating premarket guidance and considering new post-market authority. FDA will be considering new premarket authorities that would require security updates and patches being built into a product’s design, and to provide data about this to FDA in the device’s premarket submission. This goes in hand with a possible new postmarket authority to require policies being adopted by manufacturers for coordinated disclosure of vulnerabilities. Currently manufacturers to give attention to cyber security in the pre-market registration of devices hopefully this intuitive will further build on manufacturer’s risk management process.
Now that the comment period is over, we eagerly await the FDA’s response and continued improvement of the medical device regulatory system. While several of the initiatives are excellent, will help protect consumer safety, and will drive the industry forward, the Medical Device industry hopes the FDA continues to provide opportunities to comment, ensuring the best-informed regulations are put in place.
Have questions on the what the Action Plan means for you and your medical devices? Reach out to dicentra for further information.
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Center for Devices and Radiological Health. (n.d.). CDRH Reports – Medical Device Safety Action Plan: Protecting Patients, Promoting Public Health.
Commissioner, O. O. (n.d.). Press Announcements – Statement from FDA Commissioner Scott Gottlieb, M.D., on new efforts to enhance and modernize the FDA’s approach to medical device safety and innovation.
FDA’s Medical Device Safety Action Plan. (2018, May 08).
Pedersen, A. (2018, August 22). FDA Medical Device Safety Action Plan: Good or Bad for Medtech?