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FDA Form 483s could get easier for medical device companies: Here’s how

April 22, 2019 By Chris Newmarker

FDA Form 483s 483FDA in the U.S. is setting up a formal way for medical device companies to get nonbinding feedback about Form 483s, which raise potential manufacturing process problems.

FDA is taking comments through today about the draft guidance, which it issued Feb. 19 under a requirement in the FDA Reauthorization Act of 2017.

The proposed process actually standardizes what some in the industry have been doing for a long time: seeking nonbinding feedback from FDA about inspection results and proposed solutions, in the same way a company might hold a presubmission meeting, according to Mike Drues, a Southern California–based regulatory consultant who has worked with both companies and FDA.

“We’ve had the opportunity to have these types of conversations in the past, but not in a formal or organized way,” Drues, who is president of Vascular Sciences, explained to Medical Design & Outsourcing late last month.

Drues discussed the draft guidance during his latest podcast appearance with MDO.

About The Author

Chris Newmarker

Chris Newmarker is the executive editor of WTWH Media life science's news websites and publications including MassDevice, Medical Design & Outsourcing and more. A professional journalist of 18 years, he is a veteran of UBM (now Informa) and The Associated Press whose career has taken him from Ohio to Virginia, New Jersey and, most recently, Minnesota. He’s covered a wide variety of subjects, but his focus over the past decade has been business and technology. He holds bachelor’s degrees in journalism and political science from Ohio State University. Connect with him on LinkedIn or email at cnewmarker@wtwhmedia.com.

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  • Home
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  • Applications
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