FDA 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FDA is taking comments through today about the draft guidance, which it issued Feb. 19 under a requirement in the FDA Reauthorization Act of 2017.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Drues discussed the draft guidance during his latest podcast appearance with MDO.
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