Medical Devices

User Session - Digital Health Software Precertification (Pre-Cert) Pilot Program - February 7, 2019

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On Thursday, February 7, 2019, the U.S. Food and Drug Administration (FDA) will host an interactive user session for Software Precertification Pilot Program participants, software as a medical device developers and medical device manufacturers to discuss progress the agency has made on the Software Precertification Pilot Program.

The session will dive deep into the recently-released version 1.0 of the Pre-Cert working model, test plan, and regulatory framework. These documents detail how the FDA has reimagined its way of regulating digital health devices towards a total product lifecycle approach that enables the FDA to evaluate software products from premarket development to postmarket performance, along with continued demonstration of the manufacturer’s excellence. The FDA encourages software developers to review the working model, the test plan, and the regulatory framework before the session.

For more ways to stay engaged in the pilot program, visit the Software Precertification Pilot Program Webpage.

Page Last Updated: 02/15/2019
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