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Retractable Technologies’ device history records do not include a cycle chart for part of the sterilization cycle used by one of the company’s contract sterilizers for 1cc and 3cc VanishPoint syringe product lines, according to a recent Form 483. Read More
The International Medical Device Regulators Forum will launch its medical device single audit program (MDSAP) pilot in January in the U.S., Canada, Australia and Brazil. Read More
Medtronic was slapped with a 15-citation warning letter following a preapproval inspection for its MiniMed 530G continuous glucose monitoring system. Read More
FDA investigators increasingly are shifting from “top down” inspections focused on policies to “bottom up” inspections that focus on raw data, an industry insider says. Read More