FDA Pre-Cert

By Dave Muoio June 4, 2019
Since it was first announced, fans and critics of the FDA’s Pre-Cert program for medical software developers have mused on the benefits and burdens that might come with participation in the experimental program. What to expect from Pre-Cert The question has only become more pertinent since the agency released its 1.0 Working Model in January and, just a couple weeks ago, began seeking new De Novo...
By Dave Muoio May 22, 2019
The FDA has put out a call for new companies to test drive the current framework of its Digital Health Software Precertification Program, the ongoing effort to streamline regulation of digital health products prone to frequent update. Organizations that are expecting to sponsor either a 510(k) submission or De Novo Request for a software as a medical device (SaMD) during 2019 or early 2020 are...
FDA Pre-Cert panel at Connected Health Conference

(L to R) Moderator Scott Thiel, Pear Therapeutics' Dan Amor, Verily's Afia Asamoah, Tidepool's Howard Look, and Johnson & Johnson's Eduardo Sanchez (photo by Jonah Comstock)

By Jonah Comstock October 19, 2018
Attendees to the Connected Health Conference in Boston this week got a sneak peek into the workings of the FDA's much-discussed Pre-Cert program. In a panel discussion at the event, representatives from Verily, Pear Therapeutics, Tidepool, and Johnson & Johnson candidly discussed their experiences so far with the program, describing an evolving process that is collaborative and rigorous.  "...

Senator Elizabeth Warren at a rally in Cambridge, Massachusetts, in September. Photo by Scott Eisen, Getty Images

By Jonah Comstock October 10, 2018
The FDA’s Pre-Cert program has fallen under new scrutiny as the agency received an open letter today from three senators: Elizabeth Warren (D-Mass.), Patty Murray (D-Wash.), and Tina Smith (D-Minn.). The 12-page letter contains no less than 50 questions for the agency about the program, ranging from how it will derive its statutory authority to how it will pay for the program absent traditional...