FDA updates Pre-Cert program as it begins to grapple with ‘hard questions’

Scott Gottlieb FDA
A software precertification program launched by FDA Commissioner Scott Gottlieb is beginning to face tougher questions. (FDA)

Updates to the Food and Drug Administration’s software precertification program this week provided new clarifications to a model designed to streamline the approval process for digital health. But one expert says the agency is just beginning to broach some of the more difficult questions around legal authority and device eligibility.

The precertification pilot program, announced last year, has gained widespread industry support. Last September the agency announced 9 companies—including Apple, Fitbit and Verily—would be part of an initial pilot to develop a working model that evaluates software developers rather than individual devices.

RELATED: Apple and Fitbit among the 9 companies selected for FDA’s coveted digital health pilot

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In its updated working model (PDF), released on Tuesday, the FDA emphasized the new program will be “available for any size organization who is currently developing products in healthcare,” a response to concerns that larger, more established companies would have an advantage over startups.

The working model further refined the FDA's "excellence appraisal," which serves as a way for the FDA to measure whether a company meets a certain level of organizational excellence. The update includes new appraisal process descriptions and updated organizational practice domains that include leadership and organizational support, transparency, risk management, and infrastructure and work environment. There is also a heavy emphasis on cybersecurity.

The agency also clarified that the model will eventually include software inside medical devices such as X-ray or MRI machines. So far it's been limited to software as a medical device, including AI and machine learning.

However, the FDA has yet to clarify how it plans to approach Class I devices—lower-risk medical devices general exempt from precertification requirements.

“No matter how you slice it, this program is extra work for software that currently is in Class I,” Bradley Merrill Thompson, an attorney with Epstein Becker Green told FierceHealthcare. “I cannot imagine any class one software developer wanting to participate in this program.”

RELATED: FDA maintains its focus on digital health in 2018

While Thompson praised the concept of the precertification program and the FDA’s willingness to incorporate public comments, he said the agency has “substantially changed its tune” regarding its legal authority. In the updated working model, the FDA said it plans to develop version 1.0 of the program by the end of the year so it’s “available for pilot testing within FDA’s current authorities in 2019.”

But Thompson says that violates the current 510(K) regulation.

“I have no idea how the agency could possibly think that that’s appropriate,” Thompson said of the pilot testing. “They must think that they can generally suspend essentially all statutory and regulatory authority for a medical device pilot.”

More broadly, he’s concerned that the excitement around the new program will overshadow concerns around the agency’s legal authority.

“Now we're getting to the hard questions where we have to make choices based on FDA’s need to assure its ability to act as an enforcement agency against the industry, and industry's need to innovate,” he said. “There is conflict, and we are starting to see that conflict.”

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