The Custom Device Exemption allows medical device manufacturers to market devices designed to accommodate unique patient conditions without premarket application approval. A device that meets the qualification of a custom device is exempt from 510(k) and Premarket Approval (PMA) submissions. Manufactures of custom devices must report to the FDA annually. This year, manufactures of custom devices must submit their report to the FDA no later than March 31.
On Tuesday, February 27, 2018, the FDA will host a webinar for industry to discuss and answer questions about their custom device exemption annual report. The FDA wants to work with industry to ensure clarity and consistency when it comes to reporting. The agency wants industry to understand how to accurately report their custom devices so more Americans will have access to innovative medical devices. No registration is required.
Webinar Details:
No registration is required.
- Date: Tuesday, February 27, 2018
- Time: 3:00 – 4:30 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: 888-282-9646; International Callers Dial: 1-210-234-0021;
Conference Number: PWXW6887631; Passcode: 9437201;
To view the slide presentation during the webinar: https://www.mymeetings.com/nc/join.php?i=PWXW6887631&p= 9437201&t=c - Following the webinar, a transcript, audio recording, and slides will be available at:http://www.fda.gov/CDRHWebinar
. The slide presentation will also be available at this site on the morning of the webinar.
NOTE: The FDA does not provide Continuing Education (CEU) or Certificates of Attendance for webinar attendance.
Target Audience: Industry
If you have any questions, please contact CDRH’s Division of Industry and Consumer Education (DICE) at DICE@fda.hhs.gov, or via phone at 1-800-638-2041, or 301-796-7100.
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