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Posted by Brandy Smith on Wed, Mar 04, 2015

Who is Updating Medical Device Review Guidelines?

“The new proposal aims to fulfill a European Parliament request for more stringent med-tech scrutiny by bolstering an existing pre-market review system with additional checks and more transparency.”  Sound familiar? You might be surprised to learn that this excerpt was not in reference to FDA.

Topics: Medical Device Review Guidelines, MassDevice, FDA

Posted by John Lehmann on Fri, Jul 20, 2018

“21 CFR 50.25(c): New Requirement for Consent Forms Being Enforced”

It’s official! According to the new guidance released on the FDA’s website all applicable clinical trials initiated on or after March 7, 2012, informed consent documents must be in compliance with the new requirement in 21 CFR § 50.25(c) and include this specific statement that refers to the trial’s description on http://www.clinicaltrials.gov:

Topics: Informed Consent, Medical Device CRO, 21 CFR § 50.25(c), MassDevice

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