Updated January 18, 2017
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In-Person Ways to Avoid Form 483 Observations and Warning Letters - MDDI
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Seven Strategies for Avoiding a 483: 'via Blog this'
"What a 483 is — and isn’t. After inspecting a food, drug, medical device, or biologic establishment, FDA prepares a written report of its inspection findings, following a debriefing. This report is intended primarily for internal FDA use and is not provided to the inspected institution at the conclusion of the on-site visit."A nice, quick and easy primer on 483s.
I'm on my way out the door for a weekend of fun in the wine country. Some food, wine, and lots of sun.
It's better to know what's needed upfront, than to get hung up at the last moment in the 510k process. "FDA medical device approval, also known as the FDA 510k process, can easily take much longer than anticipated due to common mistakes or omissions. Here are five tips to avoid some of those mistakes," reports Nicolaas Besseling in, "Five Tips for Quick FDA 510k Clearance for Medical Devices." In a nutshell . . .
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