In a recent blog post, FDA Commissioner Dr. Scott Gottlieb acknowledges that demand is soaring for digital technologies which “allow consumers and providers to supercede the traditional, physical constraints of healthcare delivery,” and that resulting innovations will likely play a pivotal role in modernizing the future of medicine. Gottlieb also admits that a “traditional” regulatory approach to digital tech is insufficient; that it fails to facilitate digital health’s unique clinical potential and patient interface, and doesn’t account for a commercial cycle involving consistent updates and upgrades.
To remedy the weaknesses of traditional regulation when applied to apps, online programs, and other digital health tools, the FDA is instituting a number of new initiatives outlined in its Digital Health Innovation Action Plan.
Included in the plan is the department’s new Pre-Cert for Software Pilot Program, through which software companies whose developmental procedures meet select quality standards will be able to circumvent parts (or all) of the pre-market review process and proceed immediately to collecting postmarket data, which the FDA may evaluate to ensure products continue to serve consumers safety and effectively.
The pre-cert pilot will evaluate up to nine software firms, ranging from small startups to established organizations. Companies that produce both low and high risk medical software will be evaluated on equal terms. Gottlieb’s blog states that to be considered for selection, a company must:
- Be planning to develop, or already developing software that meets the definition of a medical device.
- Have an existing record in developing, testing, and maintaining software products, as well as demonstrating a culture of quality and organizational excellence that can be tracked by Key Performance Indicators (KPI), or similar measures.
- Agree to provide access to said KPI/measures, provide the FDA with real-world post-market data, meet with FDA for real-time consultation, be available for site visits from FDA officials, and give information about the firm’s quality management system.
According to Gottlieb, the criteria were left intentionally flexible to include the widest possible product range. Company submissions for inclusion in the program will be collected and evaluated throughout the month of August, and research will be conducted for the following four months. The FDA will then present its initial findings at a workshop in January 2018.
In addition to the pre-cert program’s rollout, the FDA plans to establish new draft guidance further clarifying the definition and policy implications of the designation “Software as a Medical Device (SaMD),” under its 21st Century Cures Act. The draft interpretations are slated for release by the end of 2017.