MASSDEVICE ON CALL — Federal healthcare regulators are inviting certain medical device companies to self-report regulatory violations, promising that companies that cooperate will get to avoid FDA inspections.
Participants must retain an outside consultant to assess manufacturing and quality assurance programs, and they must demonstrate that they have methods and resources to "define problems, analyze root causes, create appropriate corrective actions, and verify that the actions taken were effective."
Only 3-5 manufacturers will be selected to participate in the FDA’s Voluntary Compliance Improvement Program, the agency said. Participants will not be subject to routine surveillance inspections for the duration of the program and the 2 years afterward.
"The FDA supports using new approaches to help companies come into compliance," according to the FDA memo. "These approaches benefit industry and may decrease the number of inspections that the FDA performs or permit the agency to focus on manufacturers with serious and ongoing problems."
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