FDA Commissioner Gottlieb on Software Regulations: Securing Innovation in Digital Medical Devices

ACA may go away: can regulatory innovation secure the triple aim?

The new U.S. Food and Drug Administration (FDA) Commissioner is off to a great start. Barely one month since confirmation of his appointment, Dr. Scott Gottlieb published the opening chapter of his plan to improve the regulatory efficiency of the agency he leads.  We hope that he will go the distance to transform the agency into the protector and promoter of public health that it is chartered to be.  Given uncertainty about the future of achieving the triple aim (improved patient experience + better public health @ lower per capita cost) through new payment policies, the role of the FDA as the market gatekeeper for industry innovation is even more important. 

In a posting titled “Fostering Medical Innovation: A Plan for Digital Health Devices” Dr. Gottlieb has confirmed and strengthened several initiatives within the Center for Devices and Radiological Health (CDRH), the FDA unit that is responsible for most medical devices and software products.  These include:

• Issuing guidance on clinical decision support software for physicians.
• Clarifying open questions raised by software deregulatory provisions in the 21^st Century Cures Act.
• Establishing new pre-market certification programs for software, possibly including what was previously called a “Pre-chek” model for sponsors of software as a medical device (SaMD) products.
• Greater use of real world post-market data through acceleration of the MDIC-NEST initiative (Medical Device Innovation Consortium - National Evaluation System for health Technology).

As important as these specific announcements are, regulated industry may be even more excited by the change in tone or perhaps even status:

“(W)e are also announcing today a new initiative that FDA is undertaking. This fall, as part of a comprehensive approach to the regulation of digital health tools and in collaboration with our customers, FDA will pilot an entirely new approach toward regulating this technology.” Dr. Gottlieb

Central to this approach is decreasing regulatory burdens for low risk products and explicitly relying on good innovative companies to produce only safe and effective products.  These concepts, with even less regulation, have supplied consumers with a continuing supply of software tools and digital devices that typically become better AND more affordable over time. 

It is clear that medical software oversight must allow for dynamic improvement with fewer pre-market gates.  FDA’s challenge will be to ensure that this new approach:

• Does not leave out high quality companies that are new entrants to health care, including startups
• Is designed to make certain that all medical products are based on evidence and clinical validation that users can confirm
• Equips consumers, clinicians and payers to determine which products are right for their needs

Having worked for several years to move the FDA toward a more dynamic and efficient regulatory approach to medical products, we are excited by Dr. Gottlieb’s blog.  We will have more to say on these topics in the near future.