By Stephanie Baum | March 28, 2018
The FDA pre-certification pilot program for digital health kicked off last year is due for expansion in the latter half of the year, according to a new report from RAPS.
The program, run by the Center for Devices and Radiological Health, is part of the Digital Health Innovation Action Plan. It is expected to add more members between now and December. Still, Bakul Patel — digital health director at CDRH — acknowledged that the group is “still figuring out how it should look.” He added that the risk posed by tweaking the program is broadening the scope so much so that it can’t get off the ground.
Nine companies are taking part in the pilot program — Apple, Fitbit, Johnson & Johnson, Pear Therapeutics, Phosphorus, Roche, Samsung, Tidepool and Verily. The first public workshop in January raised more questions than answers, which had been expected so the apparent change in attitude is a little puzzling.
The heady challenge facing the program was summed up by App Association President Morgan Reed, who attended workshops shaped around the pilot program earlier this year, in an interview with MobiHealthNews:
“We have a situation where the manner in which the FDA is reviewing software is going to have match the way the way our industry makes software, and so that was a big part of this discussion.”
Another challenge and talking point regarding the program has been making it fair for companies of any size. The nine in the program span relatively small companies to IT and medtech giants, so it’s understandable why this has been a source of discussion.
One goal of the pre-certification program was to set up a regulatory framework for software as a medical device so that companies with established, tried and tested quality assurance protocols would be able to update their products faster. It puts the onus on the company and their quality control measures rather than focusing on each product update they execute.
Digital health companies, as well as pharma and technology businesses taking part in the pilot, have high hopes that it will reduce the complexity and time of submitting products and programs for clearance.