FDA Pre-Cert Program

By MobiHealthNews July 5, 2018
Interest in digital health is now sprouting up all over DC, from the president’s announcement of a new AI task force to FDA Commissioner’s shout out to digital health in his budget request.   In fact, the FDA is turning to developers in the digital health space to help solve some of the country’s most difficult problems. In May, the agency announced an innovation challenge aimed at tackling the...
By Jonah Comstock June 20, 2018
The FDA continues to move at a fast pace to develop and, soon, implement its pre-certification program for medical software development. Yesterday the agency released a second draft of its Pre-Cert framework, incorporating some of the comments it received about the April first draft and seeking additional comments on other parts of the framework. The basic goal of the Pre-Cert program, which sets...
By Mike Miliard April 30, 2018
At AcademyHealth’s 2018 Health Datapalooza on Thursday, the US Food and Drug Administration offered a vote of confidence for artificial intelligence in healthcare, promising more refined strategies for regulation, touting its tech incubator for AI innovation, and announcing a new machine learning partnership with Harvard. "We’re implementing a new approach to the review of artificial intelligence...
By Jonah Comstock April 26, 2018
This morning, the FDA published its 17-page first draft of a working model for its pre-certification program for software as a medical device (SaMD). Though still preliminary (the agency is asking for comments by the end of May), the publication comes with some long-awaited details about how the program might work. The document lays out five "excellence principles" on which companies applying for...
By MobiHealthNews April 6, 2018
In the last quarter the FDA gave the nod to 10 digital health devices. Innovations that aimed to help diabetes management were popular, ranging from the first integrated continuous glucose monitor, which was put out by Dexcom, to Glooko’s insulin titration tool.  Not all FDA news this quarter was good news. In February Roche’s Accu-Check Connect Diabetes Management App was recalled by the FDA for...
By Dave Muoio January 15, 2018
Last September, Tidepool — a diabetes data management platform — was among the nine companies chosen to participate in the FDA’s experimental pre-certification program pilot. Along with Apple, Samsung, Verily, Johnson & Johnson, and others, Tidepool would work with the agency to prove its overall development processes are responsible and safe, negating the need for product-by-product...
By Jonah Comstock November 2, 2017
On Fitbit’s third quarter earnings call yesterday, the company shared that, between spending cuts and the launch of the its long-awaited smartwatch, the company is pulling out of the earnings slump it’s been experiencing. The call also saw CEO James Park talking more than ever about the fitness wearable’s clinical applications and the ways in which those ambitions are coming to fruition. This...
By Jonah Comstock September 26, 2017
Just two months after announcing the applications for its pre-certification program pilot, the FDA has announced the nine companies that will be participating. The list includes major tech companies Apple and Samsung; health tech companies Verily, Pear Therapeutics, Tidepool, and Phosphorus; pharmaceutical companies Roche and Johnson & Johnson; and Fitbit — an interesting inclusion insofaras...
By Jonah Comstock July 27, 2017
The FDA is moving forward surprisingly quickly with its plan to create a pre-certification program for digital health app developers, originally announced in a blog post by new FDA Commissioner Dr. Scott Gottlieb last month. Now the agency has opened up applications for a nine-company pilot program to develop the program. The basic goal of the Pre-Cert program, which sets it apart from previous...