jueves, 2 de febrero de 2017

CDRH Industry: REMINDER - Webinar - Final Guidance on Medical Device Accessories: Describing Accessories and Classification Pathway for New Accessory Types

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On Thursday, February 2, 2017, the FDA will host a webinar to share information and answer questions about the final guidance document, “Medical Device Accessories: Describing Accessories and Classification Pathway for New Accessory Types.” The purpose of this document is to provide recommendations to industry about the regulation of accessories to medical devices. The guidance provides clarification on the definition of a medical device accessory. It recommends classifying accessories according to their level of risk when used as intended with a parent device to ensure their safety and effectiveness while reducing burden to manufacturers. It also encourages manufacturers to use the de novo process to request risk-based classification for new accessories when appropriate.
Webinar details:
Registration is not necessary
Date: Thursday, February 2, 2017
Time: 1:00 pm – 2:00 pm, Eastern Time
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: 888-566-6189; passcode 6985841 | International: 1-517-308-9280; passcode: 6985841
On the day of the webinar, use the following link to view the presentation: https://www.mymeetings.com/nc/join.php?i=PW2256316&p=6985841&t=c
Conference number: PW2256316 
Following the webinar, a transcript, recording and slides will be available at: http://www.fda.gov/CDRHWebinar. The slide presentation will be available at this site on the morning of the webinar.
NOTE: The FDA does not provide Continuing Education Credits (CEU) or Certificates of Attendance.
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.
Thank you,

Food and Drug Administration
Center for Devices and Radiological Health

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