FDA Files Intent to Exempt Some Medical Device Class II and Class I from Premarket Notification
In the commitment letter dated August 1, 2014 that was drafted as part of the re-authorization process for the Medical Device User Fee Amendments of 2012, FDA committed to identifying certain Class II medical devices to exempt from premarket notification. FDA has identified certain Class II medical devices for which FDA believes a 510(k) review is not necessary to assure safety and effectiveness before these devices enter the market place, and certain Class I medical devices which FDA believes no longer meet the “reserved” criteria at section 510(I) of the FD&C Act.
The goal of this document is to outline FDA’s intent to propose exempting the Class II and Class I reserved medical devised (list begins on Page 5) from premarket notification requirements, subject to limitations to the exemption criteria found in 21 CFR 868.9, 21 CFR 870.9, 21 CFR 872.9, 21 CFR 874.9, 21 CFR 876.9, 21 CFR 878.9, CFR 880.9, 21 CFR 882.9, 21 CFR 884.9, 21 CFR 886.9, and 21 CFR 890.9. FDA does not intend to exempt these devices from other statutory and regulatory requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and 21 CFR 809.10); good manufacturing practice requirements as set forth in the Quality System regulation (21 CFR Part 820); and Medical Device Reporting requirements (21 CFR Part 803).