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 Soliciting New Volunteers to Test Drive Its Experimental Pre-Cert Program,” by Dave Muoio.
Following is an excerpt:
The FDA’s decision to solicit new volunteers is a stark departure from the program’s original game plan, as the agency had initially selected just nine companies to participate in the Pre-Cert pilot back in 2017. What’s more, the program was previously limiting its test cases to De Novo submission, but now appears to be open to 510(k)s as well.
“As recently as January, FDA said that its plan was to limit this to those submitting De Novo’s, and that they would proceed along the two different regulatory paths simultaneously,” Bradley Merrill Thompson, a partner at Epstein Becker Green who specializes in consulting with digital health startups about FDA clearance, told MobiHealthNews in an email commentary.
“This is important because they do not have legal authority for this program from Congress. So if they are now going to open it up to companies pursuing 510(k)’s, I assume — but don’t know — that they’re planning to do a parallel 510(k) review process along with the precertification program.”
With this in mind, Thompson questioned why companies already facing the hurdles of a normal regulatory submission would be interested in acting as guinea pigs for the Test Plan — especially if their time and effort cannot yet be rewarded with precertification.