FDA precertification program

By HIMSS Media 04:31 pm 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...
By Dave Muoio 01:55 pm March 27, 2020
Yesterday, Pear Therapeutics announced the regulatory clearance of Somryst, its prescription digital therapeutic for chronic insomnia. And while the product is noteworthy for these patients and Pear's broader business, it also stands as a major milestone for the digital health industry – the first product to be evaluated throught the FDA's Digital Health Software Precertification Program. Now...
By Dave Muoio 03:53 pm 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)...
By Bradley Merrill Thompson 02:08 pm 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,...

Photo by Sean Rayford/Getty Images

By Laura Lovett 12:54 pm October 30, 2019
US senators Elizabeth Warren (D-Mass.), Patty Murray (D-Wash.) and Tina Smith (D-Minn.) have penned another letter to the FDA expressing concern over the agency’s PreCert program.  In it, the senators acknowledge the opportunities for digital health, but also question the proposed regulation's ability to ensure safety of the products. The 10-page letter asks 18 pointed questions about the program...
By Laura Lovett 02:23 pm July 23, 2019
A little over six months after the FDA moved its PreCert pilot along to the Test Plan phase, the agency released its Mid-Year Update on the program. At this stage, the original nine FDA PreCert pilot companies are now in the midst of test-driving the new Working Model. This means companies seeking to approve new products will go through the new PreCert pathway and the traditional review process...
By Dave Muoio 03:59 pm 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...
By MobiHealthNews 03:19 pm July 19, 2019
This quarter was another busy one for the FDA as it continued to reevaluate its approach to digital health amidst a changing of the guard from Dr. Scott Gottlieb to its new commissioner, Dr. Norman "Ned" Sharpless.  Among its most notable digital health actions of the past few months was the agency’s decision to put out a call for new companies to try out the current framework of its Digital...
By Dave Muoio 12:09 pm 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 Laura Lovett 03:28 pm March 28, 2019
Within the last few years the FDA has undergone a metamorphosis when it comes to digital health regulations. Though many of these are not yet solidified, a recent report by PricewaterhouseCoopers (PwC) predicts that these changes could open new doors for pharmaceutical companies looking to jump into the digital arena.  “Changes made by the FDA have made it easier for digital health products to be...