FDA unveils working model for software precertification program

Agency takes pragmatic approach that trusts vendors but also verifies safety, effectiveness and performance.

The Food and Drug Administration has released a draft working model for a new software precertification program for developers, with the intent of fast-tracking digital health products to market.

“The goal of this program is to develop a tailored and pragmatic approach that trusts the excellence of organizations, but also continually verifies the safety, effectiveness and performance of software as a medical device,” said FDA Commissioner Scott Gottlieb, MD, who announced the availability of the document Thursday at the Health Datapalooza conference in Washington.

In September 2017, the agency selected nine technology vendors to participate in a pilot project to help assess how precertified companies could bring certain types of consumer and patient applications to market without FDA premarket review or after a more streamlined premarket review process.

“Since announcing the nine pilot participants in September, the team’s been working with participants and other stakeholders to start assembling the essential building blocks of this unique and innovative program,” added Gottlieb. “This is a first high-level draft of what will be several iterations of our working model for this new program.”

Also See: FDA picks 9 vendors for digital health software precertification pilot

Gottlieb said that the FDA is seeking public feedback on the draft working model by May 31, noting that throughout the document, the agency included “challenge questions about each component of the program that we want answers to and hope to get input on.”

Bradley Merrill Thompson, an attorney at Washington-based law firm Epstein Becker Green who counsels medical device companies on regulatory issues, says he is wary of the FDA’s proposed framework for the new software precertification program.

“Industry wants faster approvals. FDA wants more control over industry. So FDA’s proposing an exchange—faster approvals for more FDA authority,” observed Thompson. “I’m not at this juncture saying that any of FDA’s requested authority to increase its power is necessarily wrong. But I am saying that industry has to review this proposal with eyes wide open.”

According to Gottlieb, the FDA plans to launch Pre-Cert 1.0—the first version of the program—by the end of 2018. “Once we get this framework firmly in place, it will be further refined in 2019,” he concluded.

Stakeholders can comment on the draft working model here.

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