CDRH outlines guidance plans for FY2022

Regulatory NewsRegulatory News | 26 October 2021 |  By 

The US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) on Tuesday released its list of guidances it intends to issue or finalize in FY2022, with new guidances planned and some documents making repeat appearances from last year's list.
As in years past, CDRH divides the list between “A-list” draft and final guidances, which are a priority, and a smaller “B-list” of draft and final guidances, which CDRH says it will publish as resources permit. (RELATED: CDRH FY2021 guidance slate includes post-EUA transition plan, Regulatory Focus 19 October 2020)
New guidances making the A-list as drafts to be issued in FY2022 include documents entitled Fostering Medical Device Improvement: FDA Activities and Engagement with the Voluntary Improvement Program, Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions, Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers. CDRH also says it plans to make select updates to its breakthrough devices program guidance and has bumped a proposed draft guidance on clinical considerations for medical device premarket submissions targeting opioid use disorder from its B-list to this year's A-list.
CDRH says it intends to issue final guidance for several of the documents it issued as drafts under last year's plan, including Remanufacturing of Medical Devices, Procedures for Handling Post-Approval Studies Imposed by Premarket Approval Application Order, and Electronic Submission Template for Premarket Notification (510(k)) Submissions. The agency also again says it plans to finalize its Clinical Decision Support Software guidance, which it had planned to finalize in FY2021.
Some holdovers remain on the draft list from last year, such as a draft guidance FDA intends to release on computer software assurance for manufacturing and quality system software and the agency's transition plan for medical devices granted emergency use authorizations (EUAs) or distributed under enforcement policies during the COVID-19 public health emergency. Other draft guidance carryovers include a guidance addressing the content of premarket submissions for software as a medical device (SaMD) and software in a medical device (SiMD) and guidance on reporting requirements for medical device shortages under the Coronavirus Aid, Relief, and Economic Security Act (CARES Act).
Most of the documents on CDRH's B-list are carryovers from last year's list, including both final guidances the agency plans to finalize if resources permit and several of the draft guidances on the list. Newly added guidances on the B-list include draft guidances on certificates for devices not exported from the United States and the content of human factors information in medical device marketing submissions.
FDA, Federal Register Notice


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