On 27 July 2017, the US Food and Drug Administration (FDA) issued its Digital Health Innovation Action Plan (Plan) (here) which outlines the Agency's efforts to restructure Its approach for regulating digital health devices. The Plan includes:

  • Issuing guidance to provide more clarity on the medical software provisions of the 21st Century Cures Act and other topics
  • Starting a pilot pre-certification program to work with industry to develop a new approach to digital health technology oversight (FDA Pre-Cert for Software); and
  • Increasing FDA’s personnel strength and expertise in Its digital health unit within the Center for Devices and Radiological Health (CDRH)

New guidance

FDA intends to issue multiple guidances:

  • A new draft guidance (by the end of 2017) with interpretations of several of the medical software provisions in the 21st Century Cures Act, explaining their effect on pre-existing FDA policy, including policy on mobile medical applications, medical device data systems, and low-risk general wellness products, among others.
  • A new draft guidance (by the first quarter of 2018) that delineates the clinical decision support software that is no longer under FDA’s jurisdiction.
  • A draft guidance (by the first quarter of 2018) on FDA oversight of products with both software functions that fall under FDA’s medical device oversight and software functions that do not.
  • A final version (by the end of 2017) of its guidance on "Deciding When to Submit a 510(k) for a Software Change to an Existing Device."
  • A final version of its guidance adopting the International Medical Device Regulators Forum's (IMDRF) approach to clinically evaluating software as a medical device (SaMD), as appropriate after IMDRF approval of the approach.

Oversight of digital health devices

The FDA is restructuring its approach to digital health medical device regulation to develop more pragmatic means to engender development and marketing of high-quality, safe, and effective digital health products in a timely fashion. As a first step, FDA is implementing a voluntary pilot pre-certification program. Under the pilot program, CDRH would “pre-certify” eligible digital health developers who demonstrate a culture of quality and organizational excellence in software design, development, and validation (testing). Pre-certified developers could then qualify to be able to market their lower-risk devices without additional FDA review or with a more streamlined premarket review. FDA is also considering the role of third party certification in facilitating FDA determinations about pre-certification as part of a broader program.

Increasing FDA expertise 

FDA is growing its digital health expertise within FDA by hiring new staff for its Digital Health Program within CDRH. FDA's goal is to build a team of experts with a deep understanding and experience with software development and its application to medical devices. FDA is also launching an Entrepreneurs in Residence program this Fall, to take advantage of input from thought leaders and others with real experience in software development to build and structure the digital health function within CDRH.

The Plan seems to signal FDA's commitment to develop a new regulatory paradigm for digital health devices. It will be interesting to follow the Agency's progress.