EMERGO SUMMARY OF KEY POINTS

• The US FDA has identified nine participants in its digital health technology and software precertification pilot program.
• FDA Pre-Cert pilot participants include firms such as Apple, Samsung, Fitbit and Johnson & Johnson.
• The FDA will provide periodic Pre-Cert pilot updates as well as a public workshop in early 2018.

The US Food and Drug Administration has named all nine participants, including both major technology companies and start-up healthcare software developers, in a new pilot program for digital health product precertification.

The FDA Pre-Cert pilot, announced earlier in 2017, is intended to overhaul how the agency regulates digital health technologies such as mobile medical applications by focusing on software developers’ design and validation processes more so than their products. The program could potentially lead to FDA precertification of qualifying companies based on how they manage software development and quality system efforts; such firms’ technologies would not have to undergo premarket review as medical devices before commercialization in the US.

Nine FDA Pre-Cert Participants

The FDA vetted more than 100 applicants for Pre-Cert pilot participation before identifying nine final selections.

Pre-Cert participants include major technology companies that have made major inroads into the digital healthcare sector in recent years; established medical device and equipment manufacturers whose product lines incorporate significant technology components; as well as new and start-up companies focused on digital and telehealth technologies.

• Apple
• Fitbit
• Johnson & Johnson
• Pear Therapeutics
• Phosphorus
• Roche
• Samsung
• Tidepool
• Verily

Under the FDA Pre-Cert program, participants will provide the agency with information on their software development, testing and maintenance processes, as well as quality management system data; regulators will use this information to build their own internal expertise regarding digital health technologies, and to establish appropriate oversight methods for this sector.

FDA plans to provide periodic updates and an early 2018 workshop on the Pre-Cert program.

Related FDA regulatory information from Emergo:

• US FDA regulatory consulting for medical device and IVD companies
• FDA cybersecurity consulting for network-connected devices and software
• Medical device design, process and software validation services
• Regulatory consulting and support for telehealth and mobile medical apps