Bradley Merrill Thompson, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was quoted in Medtech Dive, in “FDA's 2022 A-List Guidance Plan Hits on Software, Post-Pandemic Future,” by Nick Paul Taylor.

Following is an excerpt:

FDA divides its planned guidelines into an A-list featuring prioritized documents and a B-list of texts it intends to publish. This year, the A-list is topped by the final guidance on clinical decision support software, the first draft version of which was released in 2017. FDA published a revised draft text for consultation in 2019.

The agency received more than 30 comments on the original draft text, including feedback from the American Medical Informatics Association that warned the guidance may leave "lingering confusion" about the regulatory status of software. FDA received even more comments on the second draft.

FDA is now seemingly close to finalizing the guidance, positioning it to clarify when CDS meets the definition of a medical device and set out a risk-based framework for the software functions.

Bradley Merrill 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." However, he lamented that the CDS document has been five years in the making.

While Thompson was pleased that clinical decision support is an A-list priority, he expressed his disappointment that "it is almost 2022 and we are still waiting on that guidance from a 2016 piece of legislation."

Work on the final guidance is advancing alongside development of several drafts related to FDA’s regulation of software. The list of high-priority draft guidelines features a text on “Computer Software Assurance for Production and Quality System Software” that FDA had originally planned to publish in its fiscal 2021, as well as a document on cybersecurity elements of quality systems and premarket submissions.

With the increased number of cyberattacks on healthcare organizations, FDA is seeking additional legislative authorities meant to bolster medical device cybersecurity.

FDA's third high-priority software draft for fiscal 2022 is titled Content of Premarket Submissions for Software as a Medical Device (SaMD) and Software in a Medical Device (SiMD). FDA was supposed to release draft guidance on the latter by the end of fiscal 2019, with the final text following within 12 months of the close of the comment period. The failure to hit the deadline was a rare black mark against FDA in a review of MDUFA goals. 

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. The AI document is on the lower-priority list despite it being more than two years since a related discussion paper.

Thompson criticized FDA for assigning a lower B-list priority to the guidance on marketing submissions for a change control plan for AI/machine learning enabled device software functions. 

"I had thought based on the way they were promoting their activities on that topic that it would've been a higher priority. Indeed, I thought we were supposed to see that guidance this year, and now I see that it's only category B for next year. That's backsliding," Thompson said.

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