With the aim of fast-tracking digital health technologies to market, the Food and Drug Administration released a "Software Precertification (PreCert) Pilot Program” program that will certify digital health developers instead of their individual products.
“This new program embraces the principle that digital health technologies can have significant benefits to patients’ lives and to our healthcare system by facilitating prevention, treatment, and diagnosis; and by helping consumers manage chronic conditions outside of traditional healthcare settings,” said FDA Commissioner Scott Gottlieb in a blog post.
Details of the new certification were released in the FDA’s Digital Health Innovation Action Plan and include a voluntary pilot program that looks to change the agency’s traditional approach to hardware-based medical devices and introduce a process that favors the “faster and iterative design, development and validation used for software products,” according to the FDA’s write-up on the new program.
While the FDA has previously struggled with how to best regulate non-traditional medical tools, it hopes that the pilot program will help to establish a safe, effective and fast approach to regulating digital products.
Gottlieb explains in the blog post that the FDA’s goal is to review a company’s systems for software design, validation and maintenance, and then, if it is determined that the company meets quality standards, award them with a precertification that will allow the company to submit less information to the FDA than is currently required before marketing a new digital tool, or, in some cases, no information at all.
“Pre-certified digital health companies could take advantage of this approach for certain lower-risk devices by demonstrating that the underlying software and internal processes are sufficiently reliable. The post-market data could help FDA assure that the new product remains safe and effective as well as supports new uses,” Gottlieb adds.
The program is launching immediately, with companies able to submit a statement of interest by Aug. 1.