FDA Offers More Details on Digital Health Precertification Pilot

Posted 09 August 2017 By Zachary Brennan


The US Food and Drug Administration (FDA) this week sought to answer some frequently asked questions regarding the rollout of its new precertification pilot program for digital health products, which is expected to begin 1 September and only include nine participating companies.

The third-party certification program, first announced in June by FDA Commissioner Scott Gottlieb, will assess developers based on their software development, validation and maintenance practice to determine whether the company meets the necessary quality standards to be pre-certified.


While FDA is cannot estimate how long of a time commitment it will be for companies participating in the pilot, the agency says it will not be a multi-year commitment. Similarly, FDA could not offer a timeline for products that enter the pilot and receive market authorization, though it is encouraging companies to apply as soon as possible.

"Your Statement of Interest should demonstrate that you meet the pilot’s criteria listed in the Federal Register notice, which includes a description of the quality management system and your company’s plan for real-world data," the agency added.

FDA also advised that if a company is already on the path to seeking 510(k) clearance, "We encourage you to continue that process instead" of participating in the pilot.

PreCert Pilot Program - Frequently Asked Questions

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Categories: In vitro diagnostics, Medical Devices, Regulatory strategy, Regulatory intelligence, News, US, FDA

Tags: digital health, precertification pilot for digital health, FDA digital health

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