Medical Devices

User Session - Digital Health Software Precertification (Pre-Cert) Pilot Program - May 10, 2018

      

On January 30-31, 2018, the FDA held a Public Workshop - Fostering Digital Health Innovation: Developing the Software Precertification Program. Launched in July 2017, the Software Precertification Pilot Program is a voluntary pilot program that will enable the FDA to develop a tailored approach to recognizing the unique characteristics of digital technology by looking first at the software developer or digital health technology developer, rather than primarily at the product, as we do for traditional medical products.

This pilot is part of the agency’s Digital Health Innovation Action Plan that provides details and timelines for FDA’s integrated approach to digital health technology and the implementation of the 21st Century Cures Act.

On Thursday, May 10, 2018, the FDA will host an interactive session to discuss progress the agency has made on the Software Precertification Pilot Program. The session will dive deep into the program working model, which includes key program areas and questions that the agency hopes to gather public input on. The session will also include a discussion of next steps for the program. The FDA plans to build and iterate the program’s working model based on input the agency receives.

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

Webinar Details:

No registration is required.

  • Date: Thursday, May 10, 2018
  • Time: 12:00 – 1:30 PM EST (To ensure you are connected, please dial-in 15 minutes prior to the start of the webinar)
  • To hear the presentation and ask questions:
  • Dial: 877-939-8828, International Callers Dial: 1-517-308-9385; Conference Number: PWXW7322399; Passcode: 9105668
  • To view the slide presentation during the webinar: https://www.mymeetings.com/nc/join.php?i=PWXW7322399&p=9105668&t=c
  • Following the webinar, a transcript, audio recording, and slides will be available at: https://www.fda.gov/CDRHWebinar. The slide presentation will also be available at this site on the morning of the webinar.

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

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

Target Audience: Software Precertification Pilot Program participants, Software as a Medical Device developers and medical device manufacturers

If you have any questions, 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 dice@fda.hhs.gov

If you have any questions about the program, please contact FDAPre-CertPilot@fda.hhs.gov.

Page Last Updated: 06/08/2018
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