Medical Devices; Development of Design Control Inspectional Strategies; Notice of Public Meeting

Streszczenie

The Food and Drug Administration (FDA) is announcing a public meeting intended to explore and develop strategies to be utilized by FDA's investigators when inspecting a medical device facility relative to design controls, after issuing the final quality system regulation. The purpose of the meeting is to obtain information from the medical device industry and other members of the public about their perspective and practical experience in exercising design controls. This meeting is intended to provide an opportunity to work with FDA towards constructing an investigational model for design controls which will become the basis for future establishment inspections.