Bradley Merrill Thompson, Member of the Firm in the Health Care and Life Sciences practice, in the firm’s Washington, DC, office, was quoted in MobiHealthNews, in “As FDA’s Pre-Cert Plan Takes Shape, Worries Emerge About Overreach,” by Jonah Comstock.
Following is an excerpt:
This morning, the FDA published its 17-page first draft of a working model for its pre-certification program for software as a medical device (SaMD). Though still preliminary (the agency is asking for comments by the end of May), the publication comes with some long-awaited details about how the program might work.
The document lays out five “excellence principles” on which companies applying for the program would be evaluated: product quality, patient safety, clinical responsibility, cybersecurity responsibility, and proactive culture. …
In an email to MobiHealthNews, Bradley Merrill Thompson, a partner at Epstein Becker Green who specializes in FDA law, said the document is asking the industry to give the FDA a lot of power and control.
“When someone knocks on your door and says I’m from Washington and I’m here to help you, make sure you read the fine print,” he wrote. “In the case of FDA’s newly developed software precertification program, the cost for industry is pretty clear. FDA wants more power. More authority. This is a good old-fashioned trade. Industry wants faster approvals. FDA wants more control over industry. So FDA’s proposing an exchange: faster approvals for more FDA authority.”
That manifests itself in several different ways throughout the guidance, Thompson argues. Software that previously fell under enforcement discretion will now be part of the framework. Premarket reviews, while expedited, will delve deeper than they have previously. And the FDA, if the plan goes forward, would have authority to access more of a company’s records, not to mention demanding access to companies’ real-world data.
