CDRH plan for FY-2021 guidance prioritizes cybersecurity, CDS software, COVID-19 updates

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On October 16, the U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) announced the list of priority guidance documents that CDRH intends to publish this fiscal year (FY-2021). FDA also announced it is committing to review previously published final guidance documents, and updating or deleting guidance documents that no longer represent FDA’s current thinking on a regulatory issue.

CDRH separated its guidance documents agenda for Fiscal Year 2021 into three categories:

  • The “A-list”: a list of final and draft guidance documents FDA intends to publish;
  • The “B-list”: a list of final and draft guidance documents FDA intends to publish as resources permit; and
  • List of final guidance documents issued in specific look-back years (2011, 2001, 1991, and 1981) for which the agency will conduct retrospective reviews.

Most notably, in its final guidance agenda, FDA announced it intends to publish final guidance on the Safer Technologies Program (STeP) for Medical Devices, which is an expansion of their breakthrough devices program that we analyzed online here. In addition, CDRH said it is finalizing the clinical decision support (CDS) software draft guidance, which we had analyzed online here. Other A-list draft guidance documents that CDRH intends to finalize this fiscal year relate to:

  • Surgical Staplers
  • Device-Specific Criteria Guidance(s) for Safety and Performance Based Pathway Implementation
  • Product Labeling for Laparoscopic Power Morcellators

In its A-list draft guidance agenda, FDA announced the release of new software and cybersecurity guidance, saying it will publish documents related to the “Content of Premarket Submissions for Software Contained in Medical Devices” updating the guidance document that industry has relied on since 2005; the “Content of Premarket Submissions for Management of Cybersecurity in Medical Devices.” CDRH is also moving ahead with plans to issue guidance on “Electronic Submission Template for Premarket Notification (510(k)) Submissions” to follow its currently ongoing pilot program addressing electronic filing of premarket submissions in CDRH.

Additionally, FDA pledged draft guidance addressing additional or expanded studies of devices after their clearance/approval through Section 522 orders and post-approval studies. Last, there are also priority draft guidance documents listed that appear to flow from challenges faced during the COVID-19 pandemic, including the “Transition Plan for Medical Devices Distributed Under Enforcement Policies or Emergency Use Authorization (EUA) During the COVID-19 Public Health Emergency,” and a forthcoming guidance related to “Medical Device Shortages - Implementation of Section 506J of the Federal Food, Drug, and Cosmetic Act.”

Other A-list draft guidance documents that CDRH intends to publish this fiscal year include:

  • Remanufacturing of Medical Devices
  • Case for Quality Voluntary Improvement Program
  • Device-Specific Criteria Guidance(s) for Safety and Performance Based Pathway Implementation
  • Unique Device Identification: Policy on Enforcement of GUDID Submission Requirements for Certain Class I Devices

The agency also committed to reviewing certain guidance documents and compliance policy guide sections from 1981, 1991, 2001, and 2011 addressing topics such as device shelf life, reprocessing of single use devices, patient labeling, among others including for specific devices such as clinical thermometers, sunlamps, and studies for urinary incontinence devices.

Analysis of key guidance documents from Hogan Lovells will be coming as released by FDA over the coming year.

[View source.]

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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