In April 2018 the FDA published the Medical Device Safety Action Plan in which the agency first described its current framework for ensuring both existing and new medical devices are safe and effective as well as previous program enhancements that are based on a Total Product Life Cycle (TPLC) concept familiar to many quality practitioners. The document also outlines a vision of 5 points that the agency feels will “continue to refine our oversight of medical device safety throughout the TPLC”:

1. Establishing a robust medical device patient safety net in the United States by continuing to develop and increasing funding for the National Evaluation System for health Technology (NEST),
2. Exploring regulatory options to streamline and modernize timely implementation of postmarket mitigations by determining what special controls may be issued more quickly through currently authorized actions,
3. Spurring innovation towards safer medical devices by focusing more regulatory activities on safety innovation and developing new voluntary pathways for sponsors to demonstrate safety and effectiveness using modern predicate devices and performance criteria (for example, the Safety and Performance pathway),
4. Advancing medical device cybersecurity by publishing/updating cybersecurity guidance, developing a CyberMed Safety Analysis Board for expert advice and opinion, and considering new regulatory authorities, and 
5. Integrating the CDRH’s premarket and post-market offices and activities to advance the use of a TPLC approach to device safety by evaluating a new organizational structure for CDRH.

The latest activity towards this Safety and Action Plan is a call for comments on how to shift industry and agency focus towards the development and use of more modern predicate devices for determinations of Substantial Equivalence. The questions for which feedback is sought include:

• Should the FDA make public a list of devices, or manufacturers who make technologies, that rely on predicates that have been on the market for more than a certain number of years (e.g., 10 years)? If so, what would be an appropriate period of time?
• Should the FDA consider using other criteria to inform our point of reference?
• Are there other and/or alternative actions we should take to promote the development and marketing of safer, more effective 510(k) devices?
• Should the FDA consider certain actions that might require new authority, such as making at least some older devices ineligible as predicates?

The docket is open for comments until 22APR2019.

Text Copyright © 2019 Katrina Rogers