Last week’s blog post by Food and Drug Administration Commissioner Scott Gottlieb, M.D., is providing digital health innovators with a new roadmap to navigate pre- and post-market federal oversight of their products.
The topline for journalists is that in the coming months, the FDA will publish new guidance on digital health products and launch programs to monitor the industry, according to the blog post. Key timeframes and details, culled from Gottlieb’s post:
- This fall: The FDA will pilot a third-party certification program for post-market review for low-risk digital health, and a “streamlined” pre-market review process for higher risk innovations. A third-party certification could be used to assess whether a company does due diligence in design, testing and maintenance of its products, for example, Gottlieb wrote.
- In coming months: The FDA will publish guidance on what digital health products fall outside the scope of FDA regulation and how new provisions of the 21st Century Cures Act affect prior related FDA policies.
- In coming weeks: The Medical Device Innovation Consortium, a non-profit public-private partnership, will set up a governing committee comprised of patients, payers, industry representatives, health care professionals and others for a new National Evaluation System for Health Technology (NEST). NEST will be a federated virtual system to generate evidence on health technology through disparate data sources, including payer claims, electronic health records, registries and other sources. The FDA is playing a key role to implement NEST, which is expected to launch by the end of 2019.
Gottlieb explained the rational behind the strategy in his post:
“In this rapidly changing environment, ambiguity regarding how FDA will approach a new technology can lead innovators to invest their time and resources in other ventures. To encourage innovation, FDA should carry out its mission to protect and promote the public health through policies that are clear enough for developers to apply them on their own, without having to seek out, on a case-by-case basis, FDA’s position on every individual technological change or iterative software development.”
The strategy was met with applause from industry, which had been asking for clearer guidance on digital health apps, clinical decision support tools, home monitoring devices and other rapidly evolving digital health tools.
“Holy smokes,” Bradley Merrill Thompson, a lawyer with the firm Epstein Becker Green, who specializes in digital health and FDA, told CNBC. “I feel like I’ve died and gone to heaven.”
“Really good to see @US_FDA @SGottliebFDA prioritizing digital health to catalyze medicine’s future,” tweeted Eric Topol, M.D., a cardiologist, author and digital medicine researcher at Scripps Health in San Diego, Calif.