Roche and Johnson & Johnson will join the likes of Apple, Fitbit and Samsung in a US digital health pilot programme.
The FDA wants to put in place a new, more pragmatic way of evaluating digital health products that could speed up their approval by scrapping the need for a pre-market submission and allow lower levels of submission content.
To help it test this the US regulator has picked a range of pharma and tech giants to participate in the first-of-its-kind pilot, which it hopes will ‘revolutionise’ digital health.
The scheme would allow the FDA to ‘pre-certify’ digital health technology, by focusing more on the company behind it rather than primarily focusing on the product itself.
FDA Commissioner Scott Gottlieb said: “Our method for regulating digital health products must recognise the unique and iterative characteristics of these products.
“We need to modernise our regulatory framework so that it matches the kind of innovation we’re being asked to evaluate, and helps foster beneficial technology while ensuring that consumers have access to high-quality, safe and effective digital health devices. These pilot participants will help the agency shape a better and more agile approach toward digital health technology that focuses on the software developer rather than an individual product.”
Just nine firms were picked for the pilot: Apple, Fitbit, J&J, Pear Therapeutics, Phosphorus, Roche, Samsung, Tidepool and Verily. But the FDA said it had received interest from more than 100 companies.
The regulator said its selection process saw it look to include a range of different perspectives and unique approaches to digital health technology development.
Bakul Patel, associate director for digital health at the FDA’s Center for Devices and Radiological Health, said: “We are extremely appreciative of the tremendous interest in participating in the FDA Pre-cert pilot programme. The number of applicants speaks to the significant impact this approach could have on facilitating the timely advancement of software that has the potential to benefit health.
“The diversity of the Pre-cert pilot programme participants means that we will receive a variety of input on how the industry defines organisational excellence and other key performance indicators.”
As part of the pilot participants will provide the FDA with access to the measures they currently use to develop, test and maintain their software products, including ways they collect post-market data. The firms have also agreed to be available for site visits from FDA staff and provide information about their quality management systems.
