FDA Releases Plan for Digital Health Regulation


Posted August 7, 2017

Recognizing that the traditional approach to regulation cannot keep up with the fast-paced iteration of digital health products, the Food and Drug Administration (FDA) has released a plan to promote “digital health innovation.” As part of this regulatory plan, the Center for Devices and Radiological Health (CDRH) will issue new guidance, pilot a firm-based approach to reviews, and strengthen its digital health unit.

”The challenge FDA faced in the past is determining how to best regulate these non-traditional medical tools with the traditional approach to medical product review,” FDA Commissioner Scott Gottlieb wrote in a recent post on the FDA blog. “We need a regulatory framework that accommodates the distinctive nature of digital health technology, its clinical promise, the unique user interface, and industry’s compressed commercial cycle of new product introductions.”

Regulating Firms, not Products

To accomplish its objectives, CDRH launched a software precertification (PreCert) pilot program last week, one that focuses on assessing the makers of the software, not the product itself.

“The Software PreCert Pilot Program is a voluntary program that will enable us 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, which is what we currently do for more traditional medical devices. This pilot will help FDA establish the most appropriate criteria for standing up a firm-based precertification program for these new tools,” the agency said on its website.

The FDA will select up to nine participants from across the spectrum of software developers that produce both low- and high-risk products. During the pilot, the agency and participating companies will “explore the use of external software development standards to reduce premarket software documentation burden,” according to a July 28 Federal Register notice.

“The goal of our new approach is for FDA to, after reviewing systems for software design, validation, and maintenance, determine whether the company meets the necessary quality standards and pre-certify the company. Pre-certified companies could submit less information to us than is currently required before marketing a new digital health tool. In some cases, pre-certified companies could not submit a premarket submission at all,” Gottlieb wrote.

This approach should reduce the time and money it takes for developers who “reliably manufacture high-quality, safe, and effective digital health devices” to enter the market, according to the FDA.

Eligibility requirements and procedures for applying to participate in the pilot program are available in the Federal Register notice. The agency will hold a public workshop in January to report on and review its initial findings.

Additional Tactics

The Digital Health Innovation Action Plan also outlined ways the FDA intends to refine its policies and provide guidance related to digital health products. During a webinar on Aug. 1, the FDA said it plans to finalize the International Medical Device Regulators Forum approach to clinically evaluating software as a medical device, as well as issue guidance on a number of digital health-related topics through the beginning of next year. These topics include:

  • Design considerations and premarket submission recommendations for interoperable medical devices.
  • When to submit a 510(k) for a software change to an existing device.
  • Clinical decision support software that is no longer under the FDA’s jurisdiction.
  • Review of products with some software functions that are devices and some functions that are not.

In addition, CDRH intends to hire additional staff and launch an “Entrepreneurs in Residence” program this fall to expand the center’s digital health capabilities.

Earlier this summer, the FDA had announced its intention to develop a risk-based plan for digital health technology and emphasized the importance of postmarket surveillance.