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FDA Issues Medical/Dental Device Software Precertification Pilot Program Regulatory Framework

The United States Food and Drug Administration (FDA) has issued a new Software Precertification (Pre-Cert) Pilot Program working model 1.0test plan, and regulatory framework.  These documents explain how the FDA reimagined its way of regulating digital health devices by looking at information across the total product lifecycle.  In 2019, the Pilot program is entering its test phase.  During this test phase, the FDA will assess whether the Excellence Appraisal and Streamlined Review components together produce an equivalent basis for determining reasonable assurance of safety and effectiveness for a software device prior to its introduction to the market, as compared to the traditional paradigm.  While the FDA’s goal with the Pre-Cert program is to regulate digital health technologies in a way that fosters innovation, the model is based in protecting patient safety.  The FDA seeks public input on the Pre-Cert working model through the public docket by March 8, 2019.

The FDA will host a user session on Thursday, February 7, 2019, to help clarify software developers’ questions about the Software Precertification (Pre-Cert) Pilot Program, including the Pre-Cert Working Model Version 1.0.  The FDA encourages software developers to review the model, test plan, and regulatory framework before the session.

Thursday, February 7, 2019 | 1:00-2:30 P.M. Eastern Time

No registration required.  To ensure you are connected, dial in 15 minutes before the start of the Webinar.  You must dial in to hear the presentation and ask questions:

U.S. Callers Dial: 888-989-4611

Conference Number: PWXW8564436; Passcode: 1805715

International Callers Dial: 1-415-228-4969

Conference Number: PWXW8564436; Passcode: 1805715

To view the slide presentation during the Webinar use:  The FDA appreciates your feedback on its Webinar program.  After the Webinar, the FDA will provide a link to a short survey, which should take no more than 5 to 10 minutes to complete.  Your responses are confidential and will be used to improve the quality of the Webinar program.  If you have questions about the Pre-Cert pilot program, e-mail: