Expanding on the guidance it provided on June 15th, 2017, the U.S. Food and Drug Administration further clarified its plans with regard to regulation of digital health technologies in a new blog post last week. The most notable announcement, in addition to clarification on timelines for further guidance in the Digital Health Innovation Action Plan, is FDA’s new Pre-Cert for Software Pilot Program.
While the post is light on specifics — it’s a pilot program, after all — this new endeavor is an exciting and reassuring follow-up to FDA’s far vaguer initial post.
I say reassuring because I would argue that, of the two scenarios Healthbox outlined in June. Scenario One speculated that the FDA would opt for a light touch and modest regulatory barriers. That now looks like it will be closer to the truth for a few reasons:
No surprise regulation
The pre-cert program has important inclusion criteria that limit participants to those developing a “software product that meets the definition of a medical device” (more details here). While the FDA’s June guidance never claimed the agency would broadly regulate a wide swath of digital health solutions, it never said it would not either. The idea of regulation isn’t news to the companies that will participate in this pilot. By definition, they were already expecting to face some degree of regulatory oversight and this new program has the potential to alleviate some of their burden.
Exclusions, exclusions, exclusions
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
The upcoming guidance outlined in FDA’s new Digital Health Innovation Action Plan will bring welcomed clarity to countless young companies struggling to determine the impact of the 21st Century Cures Act and reconcile the pace of technological innovation with that of regulatory oversight. Forthcoming clarification on the treatment of clinical decision support software, multifunctional products, and regular software updates seem as though they will offer a wide array of exclusions for digital health companies that might otherwise have fallen under FDA purview – narrowing the scope of regulation instead of broadening it.
Post-market not pre-market
As we at Healthbox considered the potential impact of new FDA regulations back in June, our biggest concern was for the possible addition of roadblocks to the product development process. By building a program focused on firms, not products, as well as post-market data instead of lengthy pre-market trials, FDA appears committed to accelerating the digital health innovation engine rather than stifling it. Especially for a company’s follow-on products, time-to-market and capital requirements seem more likely to fall rather than rise under the pre-cert program.
These are exciting times for organizations involved in digital health and these early signs from FDA point to an agency that seems motivated to move quickly and, ultimately, reinvent itself in the eyes of entrepreneurs, investors, and industry stakeholders alike. If Gottlieb maintains his current pace, he’ll have another post for us to analyze just after Labor Day. Until then…
Photo: Getty Images
