Medical Devices

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

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.

Webinar Details:

Date: Thursday, February 7, 2019
Time: 1:00 – 2:30 PM EST (To ensure you are connected, please dial-in 15 minutes prior to the start of the webinar)

NOTE: 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:

Following the webinar, a transcript, audio recording and slides will be available at:

We appreciate your feedback on our webinar program. After the webinar, we will provide a link to a short survey, which should take no more than 5-10 minutes to complete. Your responses are confidential and will be used to improve the quality of our webinar program.

NOTE: The FDA does not provide Continuing Education (CEU) or Certificates of Attendance.

Contact Us

If you have any questions about the webinar, please contact the Division of Industry and Consumer Education (DICE) in the Center for Devices and Radiological Health (CDRH) at 1-800-638-2014, 301-796-7100 or

If you have any questions about the Software Precertification Pilot Program, please contact

Page Last Updated: 01/07/2019
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