We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
The FDA has not changed its inspection policies in the device program area, despite a court ruling last year that favored devicemaker Utah Medical in its challenge of those policies, agency spokeswoman Heidi Valetkevitch told D&DL.
The FDA announced Oct. 6 it is seeking a permanent injunction against Endotec for its illegal distribution of total joint replacement devices. Endotec has continued to distribute the devices despite warnings that it was breaking federal law, the agency said.
Device and drug manufacturers may find themselves coughing up more money to pay proposed FDA user fees that would fund the agency’s reinspections of manufacturing plants that fail initial review.
FDA may have changed its sense of urgency on Part 11 and electronic record security controls as the agency’s own emphasis has appeared to wax and wane, but one constant remains: Audit trails are critically important when dealing with FDA inspectors, experts tell D&DL.
Third-party facility inspections that find either “No Action Indicated” (NAI) or “Voluntary Action Indicated” (VAI) satisfy the FDA’s biennial establishment inspection requirement, according to the agency’s final guidance for its Inspection by Accredited Persons (AP) Program.
According to an article in the May 26, 2005, issue of The New England Journal of Medicine, survey responses from more than 100 medical school research administrators indicate a range among the educational institutions' policies regarding industry-sponsored clinical research and what constitutes scientifically feasible data for publication in peer-reviewed journals.
Medical device firms need to understand their rights if they want to efficiently survive an FDA inspection, an expert on regulatory compliance issues told attendees at a device quality conference in San Diego last week.
The FDA approved Boston Scientific sites in Quincy, Mass., and Letterkenny, Ireland, to manufacture, sterilize and distribute medical devices designed to treat coronary artery and kidney disease, the company announced last week.