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Compliance In Focus


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Posted by John Lehmann on Mon, Nov 06, 2017

Unapproved Devices on ClinicalTrials.gov?

Currently, trial results for are only required to be submitted to the online database for cleared or approved devices.  However, a November 19th proposal from the National Institutes of Health which would require trial results and descriptive information for devices and device indications that have yet to be cleared or approved by FDA would be posted on the public ClinicalTrials.gov website.  The proposal would give trial sponsors up to three years between the completion of the trial and when results need to be submitted to NIH if they are legitimately working towards reaching the market.

Topics: NIH, Unapproved Devices, FDA ClinicalTrials.gov

Posted by Jaime Wynbrandt on Wed, Mar 04, 2015

Emergency Use of Unapproved Devices

When is emergency use of unapproved devices acceptable?  The Federal Regulations explicitly state how an unapproved device should be used in an emergency situation by a physician. The FDA website also provides a training presentation on this topic.

Topics: 21 CFR 812, Unapproved Devices, FDA

Clinical Research Training Requirements
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clinical research Training requirements

This whitepaper examines the similarities and differences between various US and international regulations and place them within the context of any number of roles found within the realm of clinical research.