The Food and Drug Administration (FDA) continues to flesh out its ideas for regulation of digital health. Last week, the agency published a notice in the Federal Register, announcing a pilot program to evaluate a “new approach toward software products, including a precertification program for the assessment of companies that perform high-quality software design and testing.” Specifically, FDA will develop this program to replace the need for a premarket submission in some cases and allow for decreased submission content and/or faster review of marketing applications for software products in other cases. Certification could be used to assess whether a company "consistently and reliably" engages in high quality software design and testing, as well as ongoing maintenance of its software products. According to FDA, this is a voluntary program that will enable the agency “to develop a tailored approach toward regulating this technology by looking first at the software developer and/or digital health technology developer, rather than primarily at the product.”

During the pilot program, companies will be able to provide input on the development of the precertification program. The agency has begun to accept applications and will be deciding which companies will participate by September 1. Interested companies can read more about this program here: https://www.federalregister.gov/documents/2017/07/28/2017-15891/fostering-medical-innovation-a-plan-for-digital-health-devices-software-precertification-pilot

This pilot is one component of a comprehensive approach to clarify and streamline FDA regulation of digital health technologies. FDA has previously stated that certain digital health technologies—such as clinical administrative support software and mobile apps that are intended only for maintaining or encouraging a healthy lifestyle—generally fall outside the scope of FDA regulation. These rules were codified by Congress last year in the 21st Century Cures Act. FDA will be developing guidance that applies to technologies such as:

  1. Mobile medical applications;
  2. Medical device data systems, used for the electronic transfer, storage, display, or conversion of medical device data;
  3. Medical image storage devices, used to store or retrieve medical images electronically;
  4. Medical image communications devices, used to transfer medical image data electronically between medical devices; and
  5. Clinical decision software

HK will be closely monitoring these developments in the coming weeks and months.