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

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.

Drues discussed the draft guidance during his latest podcast appearance with Medical Design & Outsourcing.