Medical Devices

Webinar - PreCertification (Pre-Cert) Pilot Update - November 17, 2017


On November 17, 2017 from 1:30 – 3:00 PM, EST, FDA hosted 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, the FDA shared 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. The kick-off meeting, we discussed the proposed Precertification model for demonstrating a Culture of Quality and Organizational Excellence. During discussions, we stressed how organizations approach self-assessment with regard to excellence, rather than on how organizations comply with existing medical device regulatory requirements.

At this webinar, we shared the presentation and the model for demonstrating a Culture of Organizational Excellence that was discussed with the pilot participants during their kick-off meeting.

Target Audience: Industry, Digital Health Community

If you have any questions, please contact the Digital Health Team at

Page Last Updated: 09/12/2018
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