Industry Response Mixed to FDA’s Safety Action Plan

Industry stakeholders lauded the FDA’s efforts to make greater use of real-world data and to take a total product lifecycle approach to regulation as outlined in its proposed Medical Device Safety Action Plan.

However, AdvaMed and Johnson & Johnson took issue with the agency’s plan to identify areas where it might seek additional authority.

The FDA said it would consider regulatory options to streamline and modernize “timely implementation of postmarket mitigations,” exploring whether it has the authority to issue “umbrella regulations” to identify devices that may require additional training or user education beyond the physician labeling currently required.