FDA Corrects Regs on Device Bans

Federal Register Final rule: FDA is amending its regulations to correct an error in the lists of statutory and regulatory provisions that provide an opportunity for an informal hearing in connection with a ban of a device. In the list of statutory provisions at Sec. 16.1(b)(1), the agency is adding a reference to subsection (b) of section 516 of the FD&C Act (21 U.S.C. 360f), which provides for a reasonable opportunity for an informal hearing when FDA proposes a medical device ban with a special effective date. The list of regulatory provisions at Sec. 16.1(b)(2) does not include any reference to Part 895 and FDA is correcting this by adding a reference to Sec. 895.30(c), which provides for an opportunity for an informal hearing under 21 CFR Part 16 when FDA proposes a medical device ban with a special effective date. To view this notice, click here.