Welcomed New Developments in FDA’s Regulation of Digital Health Products

By Suzan Onel

On July 27, 2017, the Food and Drug Administration (“FDA”) announced the issuance of a Digital Health Innovation Action Plan (“Action Plan”) that describes the Agency’s vision for fostering digital health innovation while continuing to protect and promote public health.  See FDA Digital Health Innovation Action Plan (July 2017).

According to the Action Plan, FDA is “redesigning” and “reimagining” its approach to digital health medical devices in order to develop a pragmatic approach to optimally foster the development of high quality, safe and effective digital health products while at the same time assuring timely patient access.  As such, the Action Plan provides details and timelines for an integrated approach to digital health technology and the implementation of the medical software portions of the 21st Century Cures Act.

Specifically, FDA states that it intends to do the following between now and the first quarter of 2018:

  • Issue a new draft guidance with draft interpretations of several of the medical software provisions in the 21st Century Cures Act explaining their effect on pre-existing FDA policy,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 (“MDDS”), used for electronic transfer, storage, display, or conversion of medical device data;
    • Medical image storage devices, used to store or retrieve medical images electronically;
    • Medical image communications devices, used to transfer medical image data electronically between medical devices;
    • Low risk general wellness products; and
    • Laboratory workflow.
  • Issue a new draft guidance that delineates the clinical decision support software that is no longer under FDA’s jurisdiction.
  • Issue a draft guidance on FDA oversight of products with both software functions that fall under FDA’s medical device oversight and software functions that do not.
  • Issue a final guidance on deciding when to submit a 510(k) for a software change to an existing device subject to 510(k) premarket notification requirements.
  • Issue a final guidance adopting internationally converged principles on the clinical evaluation of software as a medical device.

FDA also plans on building its bench strength and expertise in the Center for Devices and Radiological Health’s (“CDRH”) digital health unit by hiring more staff with a deep understanding and experience with software development and its application to medical devices.  According to the Action Plan, this staff would work with reviewers, compliance officers, and others within FDA to improve the quality, predictability, consistency, timeliness and efficiency of decision-making.

Another part of the Action Plan is the creation of a precertification pilot program to collect real-world postmarket data on software developers.  FDA announced the launch of this pilot program in the Federal Register and a blog post in FDA Voice.  See FDA Notice, “Fostering Medical Innovation: A Plan for Digital Health Devices; Software Precertification Pilot Program,” 82 Fed. Reg. 35216 (July 28, 2017) and FDA Announces New Steps to Empower Consumers and Advance Digital Healthcare (FDA Voice, July 27, 2017).  In announcing this program, FDA acknowledged that its traditional approach to moderate and higher risk hardware-based medical devices “is not well suited for the faster iterative design, development, and type of validation used for software products.”   See 82 Fed. Reg. at 35216.  Further, FDA stated, “an agile paradigm is necessary to accommodate the faster rate of development and innovation of software devices as compared to other types of devices.”  Id.

The software precertification pilot program is a voluntary program that is intended to help FDA develop a tailored approach to regulating software by looking first at the software developer and/or digital health technology developer, rather than at the product.  This is a significant shift from how FDA traditionally regulates medical devices.

FDA is accepting applicants to the precertification pilot program starting August 1, 2017 and the program will begin September 1, 2017.  FDA is seeking up to nine (9) software firms reflecting a broad range of software developers– from small to large companies, including both traditional and non-traditional medtech companies, and products that range in risk from low to high.  Details of the selection criteria and process appear in the Federal Register notice.  Companies participating in the pilot will explore the use of external software development standards to reduce premarket software documentation burden.  Precertified companies that have demonstrated a culture of quality and organizational excellence could bring certain types of digital health products to market after a streamlined, less burdensome FDA premarket review or, in some cases, enter the market without FDA premarket review.

According to FDA, the goal of the precertification pilot program is to leverage customer input to develop a program that can help reduce the time and cost of market entry for software developers that FDA determines reliably manufacture high-quality, safe and effective digital health devices.  FDA held a webinar to discuss the pilot program with industry on August 1, 2017; a copy of the webinar slides may be found here.

FDA is planning to hold a public workshop in January 2018 to report on and review initial findings from the pilot program.  We will continue to closely monitor developments in this area.