miércoles, 22 de octubre de 2014

CDRH Industry: REMINDER: Draft Guidance, Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs) Webinar - October 23, 2014


On October 23, 2014 at 2:00 p.m., the FDA will hold a webinar to clarify and address questions about the Draft Guidance, Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs), which published in the Federal Register on October 3, 2014.

The webinar is intended to provide clarification on the proposed framework only. Comments on the framework should be submitted to the docket. Instructions for submitting comments are provided in the notice published in the Federal Register.

The draft guidance describes a risk-based framework for addressing the regulatory oversight of a subset of in vitro diagnostic devices (IVDs) referred to as laboratory developed tests (LDTs). It is intended to provide guidance to clinical laboratories that manufacture LDTs about how the FDA intends to enforce authorities that apply to such laboratories as medical device manufacturers under the Federal Food, Drug and Cosmetic Act.

The slide presentation for the webinar will be available on the Medical Device Webinars webpage the morning of October 23. Following the webinar the audio recording and transcript will be available in the same location.

Webinar Details:

Date:  Thursday, October 23, 2014

Time:  2:00 PM – 3:30 PM, Eastern Time. To ensure you are connected, please dial-in at 1:45 PM.

Dial: 888-945-5897passcode: 8862552
International Callers: 1-517-308-9291           
NOTE: You must dial-in to hear the presentation and ask questions

To view the slide presentation during the webinar: https://www.mymeetings.com/nc/join.php?i=PW8836241&p=8862552&t=cConference number: PW8836241
Audience passcode: 8862552
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

Food and Drug Administration
Center for Devices and Radiological Health

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