March 30, 2020
These have been turbulent times for the FDA. On the one hand, the U.S. regulator has found itself carefully unravelling guidances to bolster COVID-19 testing and treatment – sometimes leading to confusion for companies searching for new ways to combat the global epidemic. On the other, the agency continues to push forward with broader initiatives to remap its processes so that novel software...
March 26, 2020
Pear Therapeutics announced this morning that Somryst, its prescription digital therapeutic for adults with chronic insomnia, has received marketing authorization from the FDA.
The treatment provides cognitive behavioral therapy for insomnia (CBTi) alongside personalized, algorithm-generated sleep restriction recommendations. The digital therapeutic was reviewed through the agency's 510(k)...
December 30, 2019
The back half of 2019 saw an FDA in the midst of a transition — both in terms of personnel and in digital regulation strategy.
On the former, the agency seems to finally be regaining its legs since the unexpected March resignation of its former head, Dr. Scott Gottlieb. After a rotating door of acting commissioners — consisting of Dr. Ned Sharpless from the National Cancer Institute and more...
November 1, 2019
About the Author: Bradley Merrill Thompson is a member of the firm at Epstein Becker & Green, P.C. There, he counsels medical device, drug, and combination product companies on a wide range of FDA regulatory, reimbursement and clinical trial issues. The opinions in this piece are Thompson's and don't necessarily reflect the opinions of MobiHealthNews or HIMSS.
Let’s say I could show you,...
September 27, 2019
It’s been two years since the first software-only digital therapeutic got the FDA greenlight, but the industry is still very much in its infancy and continuing to evolve. New entrances are emerging from the world of health, pharma, tech and finance. As the industry matures, it's grappling with existential questions including regulation, reimbursement models and, as always, the definition of a...
July 22, 2019
Prescription digital therapeutics company Pear Therapeutics announced late last week that it has filed an FDA marketing authorization for Somryst, its digital cognitive behavioral therapy for the treatment of adults with chronic insomnia and depression.
While an approval from the agency would mark the third authorized prescription digital therapeutic for Pear — behind reSET for substance use...
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...
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...
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.
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...