Tuesday, April 7, 2020

Tuesday, April 7, 2020

U.S. FOOD AND DRUG ADMINISTRATION: Implementation of Final Rule on Human Subject Protection: Acceptance of Data from Clinical Investigations for Medical Devices - March 19, 2019

U.S. Food and Drug Administration recently issued the following announcement. 

On Tuesday, March 19, 2019, the FDA will host a webinar to share information and answer questions regarding the implementation of the final rule on “Human Subject Protection; Acceptance of Data From Clinical Investigations for Medical Devices.” The rule updates the standards for accepting clinical data from clinical investigations conducted inside and outside the United States to protect human participants, and to help ensure the quality and integrity of data obtained through such investigations.

The FDA issued this final rule on February 21, 2018, along with guidance providing clarification and recommendations to help stakeholders understand and comply with the updated requirements in the final rule. The final rule applies to all clinical investigations that enroll the first subject on or after February 21, 2019, and support investigational device exemptions (IDE), premarket notifications (510(k)), requests for De Novo classification, premarket approvals (PMA), product development protocols (PDP), or humanitarian device exemptions (HDE).

Webinar Details:

Registration is not necessary.

Date: Tuesday, March 19, 2019

Time: 3pm - 4:30pm, 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: 800-779-1537


International Callers Dial: 1-517-308-9336


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.

We appreciate your feedback on our webinar program. Following the webinar, we will provide a link to a short survey about your FDA CDRH webinar experience, which should take no more than 5-10 minutes to complete. Your responses are confidential and will be used to help ensure the quality of our webinar program.

Original source can be found here.

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