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Compliance In Focus


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Posted by Lauren Luzar on Wed, Aug 10, 2016

Postmarket Surveillance Under Section 522

The FDA issued the guidance “Postmarket Surveillance Under Section 522 of the Federal Food, Drug, and Cosmetic Act” on May 16th, 2016. Section 522 of the FD&C Act provides the FDA with the authority to require manufacturers to conduct postmarket surveillance of certain class II or class III devices.

Topics: Section 522, Post Market Surveillance

Posted by Leonard Basobas on Thu, Nov 05, 2015

The Post Market Surveillance Study

 A police siren blares, but only for a brief moment indicating that the police officer just wanted to make his presence known.

In turn, your surprise quickly morphs into frustration as you see the flash of red and blue lights in your rear view mirror.  You pull to the side of the road.

“Do you know why I pulled you over?” the officer posits staring at a roll of papers in his hand.

“Honestly, I am at a loss sir?” you sarcastically reply.  “I just got on the highway to test out my new car, which is just off the assembly line, I might add, and I wasn’t even up to the speed limit yet.”

Topics: FDA, Post Market Surveillance Study, Section 522

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