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Healthcare Alert

  • Opens application process and public comment period for precertification pilot program
  • Nine companies to be chosen by September 1, 2017

Last June, FDA Commissioner Scott Gottlieb made his first public statement as Commissioner by announcing the imminent rollout of a new "Digital Health Innovation Plan." This statement signaled his intent to prioritize the agency's efforts to create – and clearly articulate – a regulatory regime that promises to "help innovators navigate a new, modern regulatory process" that will efficiently enable the delivery of safe and effective digital health technologies to patients and consumers.

On July 28, FDA formally rolled out its Digital Health Innovation Action Plan, along with a process for companies to apply to participate in one key component: the Software Precertification Pilot Program. The Action Plan describes several concrete deliverables that the agency plans to complete by the first quarter of 2018 to put a "reimagined" regulatory regime for digital health technologies in place. This will include:

Issuing guidance to clarify FDA's interpretation of certain provisions of the 21st Century Cures legislation that addressed the agency's authority (or lack thereof) over certain types of technologies.

The legislation addressed aspects of preexisting FDA policy regarding certain types of low-risk technologies, including some mobile medical applications, medical image storage devices, medical image communications devices, laboratory workflow, and general wellness products. FDA intends to issue a draft guidance for public comment regarding the effect of the legislation on this policy by the end of 2017.

In addition, FDA will publish draft guidance documents for public comment on other items addressed by the legislation, including clinical decision software, multifunctionality (i.e., products containing software with some functions subject to FDA regulation and other functions that are not), and clarifying when a 510(k) submission is required for a software change to an existing device. The first two (clinical decision software and multifunctionality) are slated for the first quarter of 2018, and the other (510(k)s for changes to existing devices) by the end of 2017. FDA also noted that it intends to issue a final guidance document adopting the internationally converged principles set forth in the proposed document of the International Medical Device Regulators Forum relating to the clinical evaluation of software as a medical device (SaMD), if the IMDRF Management Committee votes to adopt the document this September, as expected.

Building FDA's expertise.

The agency promises to focus on building an expertise on digital health by hiring new staff for the digital health unit of the FDA's Center for Devices and Radiological Health (CDRH) and launching an "Entrepreneurs in Residence" program this fall, in which thought leaders and experts in software development will advise on how to build and structure the digital health function within CDRH. The intent is to build a group of experts with a deep understanding of software development who will work with reviewers, compliance officers, and others to "improve the quality, predictability, consistency, timeliness, and efficiency of decision making on individual products and firms."

Software Precertification Pilot Program **Comment/Application Period Open**.

This program is designed to evaluate a new approach for regulating software products, potentially allowing for less oversight of products designed and tested by a company precertified by FDA (upon establishing to FDA that it performs high-quality software design and testing). In the July 28 Federal Register, FDA announced the opening of a docket, inviting the public to comment on this model and inviting companies that meet certain criteria to apply to participate in the pilot program. The criteria are as follows:

  1. The company must be developing or planning to develop a software product that meets the statutory definition of a "device";
  2. The company has an existing track record of developing, testing, and maintaining software products demonstrating a culture of quality and organizational excellence measured and tracked by Key Performance Indicators (KPIs) or other similar measures; and
  3. While participating in the pilot, the company must agree to provide access to KPIs (or other, similar measures), collect real-world postmarket performance data and provide it to FDA, be available for real-time consultations with FDA and site visits from FDA, and provide information about the quality management system.

FDA has begun collecting "statements of interest" for participation in the pilot and will continue to do so on a rolling basis throughout the duration of the program. Nine companies will be selected as the first participants by September 1, 2017.

The pilot will inform the development of a precertification program that could greatly simplify and accelerate the development of medical health technologies. FDA notes in the Federal Register notice that this could enable precertified companies to bring certain types of digital health products to market without FDA premarket review or, alternatively, after a streamlined, less burdensome premarket review. In addition, it could result in the establishment of a third-party certification program, by which third parties would facilitate the precertification of companies.

If you have any questions about the FDA's Action Plan, including the Precertification Pilot Program, please contact the authors.