jueves, 18 de abril de 2019

Reminder: FDA Webinar - Medical Devices Containing Materials Derived from Animal Sources (Except for In Vitro Diagnostic Devices) Final Guidance - April 23, 2019



Reminder: FDA Webinar - Medical Devices Containing Materials Derived from Animal Sources (Except for In Vitro Diagnostic Devices) Final Guidance - April 23, 2019


On March 15, 2019, the U.S. Food and Drug Administration (FDA) issued the final guidance, “Medical Devices Containing Materials Derived from Animal Sources (Except for In Vitro Diagnostic Devices).” The role of animal-derived material in medical devices is well established. However, the use of animal materials introduces the risk of disease transmission from animals to humans. The recommendations provided in this final guidance are intended to help manufacturers identify the possible risks related to tissues from animal sources when these tissues are used in medical devices. This guidance also provides recommendations on how to minimize these risks.

On Tuesday, April 23, 2019, the FDA will host a webinar for manufacturers and others interested in learning more about this guidance.

Webinar Details:

Date: Tuesday, April 23, 2019
Time: 3:00 – 4:30 PM Eastern Time

To ensure you are connected, please dial in 15 minutes prior to the start of the webinar.

NOTE: You must dial-in to hear the presentation and ask questions:

U.S. Callers Dial: 888-282-0360
CONFERENCE NUMBER: PWXW8886043, PASSCODE: 4098317

International Callers Dial: 1-517-308-9414
CONFERENCE NUMBER: PWXW8886043, PASSCODE: 4098317

To view the slide presentation during the webinar:

Following the webinar, a transcript, recording, and slides will be available at:http://www.fda.gov/CDRHWebinar.

NOTE: The FDA does not provide Continuing Education (CEU) or Certificates of Attendance for webinar attendance.

Target Audience: Industry

If you have questions, please contact CDRH's Division of Industry and Consumer Education (DICE) at DICE@fda.hhs.gov, or by phone at 1-800-638-2041, or 301-796-7100.

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