Following the rollout of a pre-certification pilot program for digital health technology and software developers, the US Food and Drug Administration has identified and answered several frequently asked questions regarding participation.
The FDA’s new FAQ covers key aspects of the agency’s new Pre-Cert for Software pilot program, intended to allow access for qualifying digital health product developers to the US market without extensive premarket review.
US regulators opened the Pre-Cert program to voluntary participants starting August 1, 2017, and plan to begin the program on September 1, 2017; nine participants will be accepted, according to the FAQ. Interested companies may apply electronically or via written submissions to the FDA.
The FDA has listed several eligibility requirements for companies interested in participating in the pilot, including:
According to the FDA FAQ, digital health software developers should bear in mind the following issues when considering whether to apply for participation in the Pre-Cert pilot: