Webinar Materials

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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 included 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 responded to manufacturers’ questions on the current policy.

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 [email protected], 1-800-638-2041, or 301-796-7100.

Food and Drug Administration
Center for Devices and Radiological Health