FDA Proposes Guidance for Device Metaverse

The FDA wants your comments on its recently released list of proposed draft and final medical device guidance documents for 2022. The agency divides the guidelines into an A-list featuring prioritized documents and a B-list of texts it intends to publish.

You’ve got until November 26, 2021, to make your comments.

In a sign of accelerating use of artificial intelligence, machine learning, and “smart” devices, the list, released on October 27, 2021, is heavy on documents related to software and clinical decision software (CDS). Four high-priority documents address software.

In addition, as we’ve previously reported, rising cyberattacks on healthcare organizations is causing the agency to seek additional legislative authorities to strengthen medical device cybersecurity.

Welcome to the Medical Metaverse regulatory scheme.

From the list below, you’ll see the agency plans to issue two draft documents regarding transition plans for devices covered by COVID-19 enforcement policies or emergency use authorizations. Test developers will need to get diagnostics authorized using traditional premarket review processes to support post-pandemic use.

The A List

On this list are prioritized final guidance documents the agency plans to publish in the next year. These documents include:

• Clinical Decision Support Software
• Postmarket Surveillance Under Section 522 of the Federal Food, Drug, and Cosmetic Act
• Procedures for Handling Post-Approval Studies Imposed by Premarket Approval Application Order
• Remanufacturing of Medical Devices
• Unique Device Identification: Policy Regarding Global Unique Device Identification Database Requirements for Certain Devices
• Electronic Submission Template for Premarket Notification (510(k)) Submissions

The draft guidance topics on the A list include:

• Computer Software Assurance for Production and Quality System Software
• Fostering Medical Device Improvement: FDA Activities and Engagement with the Voluntary Improvement Program
• Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency
• Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency
• Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions
• Content of Premarket Submissions for Software as a Medical Device (SaMD) and Software in a Medical Device (SiMD)
• Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers
• Select Updates for the Breakthrough Devices Program Guidance: Reducing Disparities in Health and Health Care
• Medical Device Shortages – Implementation of Section 506J of the Federal Food, Drug, and Cosmetic Act
• Clinical Considerations for Medical Device Premarket Submissions Targeting Opioid Use Disorder

MEDTECHDIVE reported that Bradley Thompson, attorney at Epstein Becker Green, said the “software flavor” to the agency’s 2022 agenda is important because “there is tremendous need in clarifying how the general medical device requirements apply to software” which in many cases is “a different beast than hardware.”

The B List

The agency’s B-list of lower priority guidance documents also features two software-related drafts. The agency plans to release drafts on Marketing Submission Recommendations for A Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions and Risk Categorization for Software as a Medical Device in its next fiscal year.

Comments Wanted

The FDA is seeking comments on the relative priority of guidance documents on the A-list and B-list, as well as proposed policy or information for the FDA to consider for inclusion in these guidances. The agency says it welcomes suggestions for new or different guidance documents and the reasons why a guidance on the topic is needed.

You can submit written comments to the Dockets Management Staff, Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Identify comments with docket number FDA-2012-N-1021 for “Notice to Public of Website Location of CDRH Fiscal Year 2022 Proposed Guidance Development.”

Submit electronic comments to www.regulations.gov. Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday.