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# FDA Corrects Regs on Device Bans
- URL: https://www.fdaweb.com/fda-corrects-regs-on-device-bans/
- Published: 2016-08-11T12:00:00.000Z
- Updated: 2026-09-14T21:23:51.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5136483

*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.](https://www.gpo.gov/fdsys/pkg/FR-2016-08-11/pdf/2016-18787.pdf?ref=fdaweb.com)