The FDA yesterday named the nine companies that will be included in a pilot program to pre-certify healthcare software developers. The program was designed with the hopes of reducing the amount of information the regulatory watchdog requires for review.
The program represents a shift for the agency, focusing on the developer instead of the product.
“Our method for regulating digital health products must recognize the unique and iterative characteristics of these products,” FDA commissioner Dr. Scott Gottlieb said in prepared remarks. “We need to modernize our regulatory framework so that it matches the kind of innovation we’re being asked to evaluate, and helps foster beneficial technology while ensuring that consumers have access to high-quality, safe and effective digital health devices.
“These pilot participants will help the agency shape a better and more agile approach toward digital health technology that focuses on the software developer rather than an individual product.”
The FDA plans on reviewing the software developers’ systems based on design, validation and maintenance. If the company meets the agency’s quality standards, they will be pre-certified.
The regulatory group said that it hopes the program will help it find ways that pre-certified companies could submit less information before marketing a new digital health product. The FDA added that it is also considering whether, and how, companies that are pre-certified may not have to submit a product for premarket review.