Bradley Merrill Thompson, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was quoted in MobiHealthNews, in “FDA Looks to De Novo Pathway Model as it Unveils Updates to Pre-Cert Program,” by Laura Lovett.
Following is an excerpt:
The FDA unveiled new updates on the ongoing Pre-Cert program including a Digital Health Innovation Action Plan, Pre-Cert Test Plan for 2019 and a Working Model.
One of the big take aways from yesterday's announcement is that the FDA is looking to use the De Novo model to implement the next phase of the Pre-Cert pilot. The second is that the organization plans on setting up a parallel submission review process that compares the streamlined De Novo Pathway to the traditional submission pathway. …
But since FDA released the new documents yesterday industry players have had mixed reviews.
Bradley Merrill Thompson, a partner at Epstein Becker Green who specializes in consulting with digital health startups about FDA clearance, took issue with the new De Novo component of the Pre-Cert proposal.
“It’s in those two documents that FDA really fleshes out the idea that initially, only software as a medical device that would qualify for a de novo submission will be included in this pilot program,” Thompson wrote in an email to MobiHealthNews. “As you undoubtedly know, the de novo process is restricted for devices that are unlike any that have ever come before. Hence the name de novo. More specifically, it is for devices for which there is no existing classification. They are unprecedented.”
