Submitted by kBLASTER Team on
by Ropes & Gray LLP
Legal commentary on medical device regulatory developments related to Food and Drug Administration Safety and Innovation Act (FDASIA) includes a number of important provisions regarding medical devices.
Excerpt below from commentary discusses developments relevant to predicate selection:
Medical Device Regulatory Improvements: FDASIA includes a number of important provisions regarding medical devices:
Least Burdensome Standard: For 510(k)s, FDASIA clarifies that FDA can mandate only the “minimum required” clinical information to support approval or clearance. For 510(k)s, FDASIA further clarifies that the clinical information must support a determination of substantial equivalence between a new device and a predicate device; this provision appears intended in part to constrain 510(k) reviewers from requesting data not directly relevant to a substantial equivalence determination.
Device Modifications: FDASIA requires FDA to withdraw its draft guidance published in July 2011 on modifications to 510(k)-cleared devices, which industry feared would increase the number of 510(k) submissions required for minor device modifications, and requires FDA to submit a report to Congress within 18 months on the subject of device modifications.