Bradley Merrill Thompson, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was quoted in FDA Week, in “FDA Officials: Too Soon to Answer Device Industry Pre-Cert Questions,” by David Roza. (Read the full version – subscription required.)

Following is an excerpt:

Officials from FDA’s device center say it is too early to answer many of industry’s questions about the agency’s nascent digital health software precertification program, including those asking what new authority FDA needs to implement the program. A medical device industry lawyer told Inside Health Policy he is especially concerned FDA will proceed with the program without legislative authority, instead relying on special controls as a “loophole."

After building on the concepts of precertification and iterating on its working model in 2018, FDA will dedicate the year ahead to testing out the pre-cert program and finding answers to many of those unresolved questions, the FDA officials told stakeholders during a Thursday (Feb. 7) webinar.

The list of unanswered questions include: What new authorities will FDA require to implement pre-cert? How will FDA consider third-party reviewers in the excellence appraisal (EA) process? How long will streamlined reviews take for pre-certified companies? When and how will FDA establish a library of Key Performance Indicators to prepare companies for the excellence appraisal process? When will FDA announce its next steps in the pre-cert development process?

Brad Thompson, a member of the firm Epstein Becker Green, told Inside Health Policy he was concerned by the lack of answers to many of the stakeholders’ questions.

A big question for Thompson is whether FDA has statutory authority to implement pre-cert in the long run. FDA temporarily resolved that issue in January by saying that it would implement the pre-cert test program under its authority for the de novo pathway.

However, “FDA continues to suggest that they might proceed with the program after 2019 even without legislative authority, and I find that troubling,” Thompson said.

FDA is acting as though it can use the special controls element of de novo as a loophole. But special controls are meant to be additional controls FDA can impose on Class II products, not vehicles for eliminating amendments and changing the 510(k) and postmarket surveillance processes, Thompson argued.

“All of those things are specified by Congress in the statute, and FDA cannot simply cast them aside simply because they issue a special control,” he said.

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