The FDA’s current policies include regulatory requirements for the use of color additives in medical devices and recommendations for manufacturers who want to market a device that contains a color additive.
This webinar will include an overview of the FDA’s current policy on color additives for medical devices and the agency’s approach to the evaluation of marketing applications (i.e. premarket notifications (510(k)), premarket approvals (PMA), de novo requests, and Humanitarian Device Exemptions (HDE) for medical devices containing color additives. It is intended to help medical device manufacturers understand current FDA policy on the use of color additives for medical devices and is part of the agency’s ongoing industry education on the regulation of medical devices.
Following a brief presentation, the FDA will respond to manufacturers’ questions on the current policy.
Registration is not necessary.
Date: Friday February 12, 2016
Time: 2:00PM – 3:30PM Eastern Time (please connect by 1:45PM)
To hear the presentation and ask questions:
Dial: 888-942-9714 Passcode: 6003238 | International callers dial: 1-210-234-0077
To view the slide presentation during the webinar:
Conference number: PW6910243
Audience passcode: 6003238
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 for webinar attendance.
Target Audience: Industry
If you have general questions about the use of color additives in medical devices, contact CDRH's Division of Industry and Consumer Education (DICE) at firstname.lastname@example.org, 1-800-638-2041, or 301-796-7100.
Food and Drug Administration
Center for Devices and Radiological Health