Bradley Merrill Thompson, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was quoted in multiple publications discussing the Food and Drug Administration’s (FDA) recent update to the pilot software pre-certification program.
Following is an excerpt from FierceHealthcare, “FDA Updates Pre-Cert Program as It Begins to Grapple With ‘Hard Questions,’” by Evan Sweeney.
Updates to the Food and Drug Administration’s software precertification program this week provided new clarifications to a model designed to streamline the approval process for digital health. But one expert says the agency is just beginning to broach some of the more difficult questions around legal authority and device eligibility.
The precertification pilot program, announced last year, has gained widespread industry support. Last September the agency announced 9 companies — including Apple, Fitbit and Verily — would be part of an initial pilot to develop a working model that evaluates software developers rather than individual devices. …
“No matter how you slice it, this program is extra work for software that currently is in Class I,” Bradley Merrill Thompson, an attorney with Epstein Becker Green told FierceHealthcare. “I cannot imagine any class one software developer wanting to participate in this program.”
While Thompson praised the concept of the precertification program and the FDA’s willingness to incorporate public comments, he said the agency has “substantially changed its tune” regarding its legal authority. In the updated working model, the FDA said it plans to develop version 1.0 of the program by the end of the year so it’s “available for pilot testing within FDA’s current authorities in 2019.”
But Thompson says that violates the current 510(K) regulation.
“I have no idea how the agency could possibly think that that’s appropriate,” Thompson said of the pilot testing. “They must think that they can generally suspend essentially all statutory and regulatory authority for a medical device pilot.”
Related reading:
- POLITICO Morning eHealth, “FDA Rolls Out Pre-Certification Update,” by Darius Tahir.
- Healthcare Dive, “FDA Unveils Software Pre-Cert Update,” by Meg Bryant.
- MobiHealthNews, "FDA's Second Draft Shows Pre-Cert is Coming Along, Still Has a Ways to Go," by Jonah Comstock.
- FDA Week, “Industry Attorneys: New Pre-Cert Model Vague on Requirement Details,” by David Roza. (Read the full version – subscription required.)
- Healthcare IT News, “FDA’s Second Draft Pre-Cert Released But Real Rule-Making Needed,” by Jonah Comstock.
