FDA Pilots Program to Pre-Certify Digital Health Software
As healthcare undergoes a digital transformation and we grow comfortable with health and fitness wearables, as well as software that supports the clinical decisions physicians make, how can the traditional regulatory process keep pace? As part of an effort to modernize the regulatory framework for the U.S. Food and Drug Administration’s medical device program and bring digital health products to market quicker, the FDA recently announced the initial participants in a pilot program that will pre-certify digital health technology companies that meet quality standards for software design, validation, and maintenance.
The focus is on the digital health developers, instead of a particular software app, and is part of the agency’s Digital Health Innovation Action Plan, which enables a more agile approach toward digital health technology.
The nine initial participants represent high- and low-risk medical device software products, medical product manufacturers, and software developers: Apple; Fitbit; Johnson & Johnson; Pear Therapeutics, Boston; Phosphorus, New York; Roche Holding AG, Switzerland; Samsung Electronics Co., Seoul, South Korea; Tidepool, Palo Alto; and Verily Life Sciences (a subsidiary of Alphabet focused on life sciences and healthcare), Mountain View, California.
As part of the program, participants will provide access to their development, testing, and maintenance processes, including ways they collect post-market data. The FDA will leverage the information obtained through the pilot program to identify ways that pre-certified companies could potentially submit less required information as part of a formal regulatory framework for medical devices.
“Some of the most creative, and forward-leaning advances in regulatory policy involve what we’re doing on the device side of FDA’s house,” said FDA Commissioner Scott Gottlieb, M.D. in a speech at the AdvaMed MedTech Conference in San Jose, where he announced the initial participants.
Gottlieb said digital health products that are deemed as “lower risk” could potentially be marketed without FDA premarket review, and “higher risk” products could be marketed with a streamlined FDA premarket review. “Pre-certification is used to assess, for example, whether a company consistently and reliably engages in high quality software design and testing, and whether it has good, ongoing maintenance of its software products. Employing a unique pre-certification program for software as a medical device could reduce the time and cost of market entry for digital health technologies.”
Updates about the FDA’s PreCert pilot program will be available via the pilot program webpage. Further clarification is available in the FDA’s guidance document: Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices.
Finally, if you’re involved with developing a mobile health app, here’s the FTC’s interactive tool with guidance for which federal laws apply.