Bradley Merrill Thompson, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was quoted in Medtech Insight Pharma Intelligence, in “Testing the Limits: Software De Novo, 510(k) Volunteers Wanted By US FDA,” by Ferdous Al-Faruque. (Read the full version – subscription required.)

Following is an excerpt:

Bradley Merrill Thompson, an attorney at Epstein Becker & Green who works with digital health, device firms and combination product-makers; said the test case open up a lot of questions about the progress the pre-cert program is making. In particular he’s curious why the FDA is now opening up the program to other companies beyond the nine firms that signed up for the pilot program.

“It makes me wonder if some of the nine have needed to drop out for some reason,” he told Medtech Insight noting that the move seems to be a departure from the agency’s position earlier this year where it seemed regulators felt they would get enough feedback from the pilot participants to develop the program.

Another issue that caught his attention is the fact the agency is now soliciting information from sponsors submitting 510(k)s.

“Again, 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,” Thompson said.

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