Health and life sciences companies have been clamoring for clear guidance for digital health for some time, begging the FDA to get with the digital program already. However, the FDA has been slow to respond knowing that overregulation could stunt innovation in a time when consumers derive significant value from digital health tools, including mobile technologies. The FDA is moving to address the unique aspects of digital health—and dare we say it—at the speed of digital.
The Software Pre-Certification (PreCert) Pilot Program has significant potential to overhaul the FDA’s approach to digital health for the better. Just one month after introducing the concept of a “pre-check” program, the agency shattered expectations of a 2018 or later conception and released program details. The program evaluates developers of Software as a Medical Device (SaMD) as opposed to the completed product.
Pre-certification depends on the developing company’s internal culture and processes meeting quality standards. With pre-cert determination given upfront, the process for pre-market review can focus on high-risk technology. Eventually, in the case of low-risk digital health technologies, ones without patient-specific analysis, diagnosis, or treatment, pre-certified companies could immediately launch a new product and forgo review all together. This will reduce the amount of pre-market submissions, as well as the time and cost of market entry for digital health technologies. Early response to the program shows companies with multiple products are grateful for the pre-certification approach.
It’s a nimble approach in line with digital design and development processes, unlike anything the agency has put out before. And just as digital technology comes into existence and remedies identified issues iteratively, the pilot program is designed to learn and adapt quickly, measuring and creating solutions to oversight in the ever-changing digital world.
To ensure program scalability, the agency welcomes companies of all sizes. However, it will only consider companies with an existing track record in developing, testing, and maintaining software products. This could potentially limit companies’ involvement in the pilot, especially during a time when non-traditional med-tech companies are entering the space and have great potential to bring digital health innovation to patients. This limited factor makes sense for the pilot as selected companies have the unique opportunity to develop and define excellence measures adopted for certification. Companies without track records likely would not have key performance indicators in place to demonstrate superior outcome measures.
The FDA is leading by example. It’s moving fast and intentionally leaving the timelines and application processes fairly open. By foregoing an application due date and keeping application criteria to a minimum, the agency is focused on selecting developers that demonstrate organizational excellence with insight to offer the agency and the pilot program. It is hosting a public meeting in January 2018 to report initial pilot findings and conduct an open dialog at that time. The meeting will be our first look into the development of excellence criteria, updated processes, and whether pre-certification has the potential to modernize an outdated, inefficient regulatory framework.
Of course, there are still many questions:
- Will the industry get the guidance details it is after, or will health and life science companies be caught up on having to do an initial determination of whether a product should be submitted for review and regulated?
- In 2016, there were 165,000 health related apps, with only 36 products cleared by the FDA. The FDA and the FTC have some overlapping jurisdiction to pursue unfair and deceptive trade practices.1 Will the approach address the current lack of oversight for digital health product claims?
- The demand of reliable evidence to substantiate claims isn’t necessarily addressed with this approach. Can the program lead to a more robust pre-market review to provide the evidence consumers seek and require to develop trust in digital health products?
It will be interesting to track the pilot’s progress in coming months to see if a common set of excellence expectations for certification really will enable an easily maintained and evolving regulatory process for digital technology. It could result in increased creation of high-quality, innovative digital technologies at reduced development costs and spur great opportunity to develop innovations that benefit consumers’ lives.