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# CDRH Proposes 18 FY 2023 Guidances
- URL: https://www.fdaweb.com/cdrh-proposes-18-fy-2023-guidances/
- Published: 2022-10-18T12:00:00.000Z
- Updated: 2026-09-14T18:03:32.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5152993

CDRH is proposing 18 guidances to be published this fiscal year, with 11 on the Center’s A-list of prioritized guidances and seven on the B-list of guidances to be published as resources permit. An online [statement](https://www.fda.gov/medical-devices/guidance-documents-medical-devices-and-radiation-emitting-products/cdrh-proposed-guidances-fiscal-year-2023-fy2023?utm%5Fmedium=email&utm%5Fsource=govdelivery) lists the A-list final guidance topics as:

- remanufacturing of medical devices;
- transition plans for medical devices that fall within Covid-19 public health emergency enforcement policies;
- transition plan for medical devices issued emergency use authorizations during the Covid-19 public health emergency;
- cybersecurity in medical devices — Quality System considerations and the content of premarket submissions;
- content of premarket submissions for device software functions;
- fostering medical device improvement — FDA activities and engagement with the Voluntary Improvement Program; and
- breakthrough device program (revised).

The A-list draft guidance topics are:

- Voluntary Malfunction Summary Reporting Medical Device Reporting for manufacturers;
- clinical considerations for medical device premarket submission targeting opioid use disorder;
- select updates for guidance for the breakthrough device program; and
- electronic submission template for de novo request submissions

The page also lists the final and draft guidance topics for the B-list, a retrospective review list of final guidances issued in 1983, 1993, 2003, and 2013, and information on how to comment on the guidance lists or a specific guidance.