FDA says industry responded positively to pilot inspection program

The FDA just released a report describing the results of the Case for Quality Inspection Pilot program. It focused on implantable devices that contain batteries. During the pilot, "Various recommendations for improvement were given, including providing easier-to-read technical guidances to investigators and improving the scope of inspections so that firms are inspected for technologies that are directly applicable to the firm's specific device," the FDA said. "The Division of Manufacturing and Quality (DMQ) in the Office of Compliance is currently developing additional Critical to Quality Information documents and procedures and policies for distribution to investigators prior to inspections and publishing them for industry access." More

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