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Bradley Merrill Thompson Quoted in “FDA Unveils Working Model for Software Precertification Program”

Health Data Management

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 Health Data Management, in “FDA Unveils Working Model for Software Precertification Program,” by Greg Slabodkin.

Following is an excerpt:

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. …

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.”