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.
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 our sister site Medical Design & Outsourcing late last month.
At DeviceTalks Boston, Tyler Shultz will give attendees an inside look at Theranos and how he was able to sound the alarm after he realized the company was falling apart. Shultz will take attendees behind the story that everyone is talking about: the rise and fall of Elizabeth Holmes and her diagnostic company, Theranos.
Join Shultz and 1,000+ medical device professionals at the 8th annual DeviceTalks Boston.