On November 17, 2017 from 1:30 – 3:00 PM, EST, FDA will host the first in a series of webinars on the Digital Health Precertification (Pre-Cert) Pilot Program. As part of our commitment to keep our efforts transparent, FDA will share updates throughout this pilot process.
FDA has held kick-off meetings with all nine pilot participants to discuss the Pre-Cert engagement plan moving forward. In the kick-off meetings we discussed the proposed Precertification model for demonstrating a Culture of Quality and Organizational Excellence. During discussions, we stressed that organizations should emphasize self-assessment with regard to excellence, rather than focusing on how organizations comply with existing medical device regulatory requirements.
At this webinar, we will share the presentation and the model for demonstrating a Culture of Organizational Excellence that was discussed with the pilot participants during their kick-off meetings.
Attendees are encouraged to stay engaged and to provide feedback through the docket for consideration. Please find more information about the precertification pilot status here .
Date: November 17, 2017
Time: 1:30 p.m., Eastern Time.
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:
Dial: 888-810-8164, passcode: 6083908
International Callers Dial: 1-212-287-1672, passcode 6083908
To view the slide presentation during the webinar:
Conference Number: PWXW6073476
Following the webinar, written transcript, audio recording and slides will be available at:
Thank you for your continued commitment to following the Software Precertification Program. We are constantly seeking broader input and your continual engagement is vital to the success of this program.