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External defibrillator MDR guidance

This article was originally published in The Gray Sheet

Executive Summary

FDA meets with manufacturers and user groups on Sept. 23 to discuss a Sept. 9 guidance outlining medical device reporting requirements for external defibrillators. At the meeting, the agency also summarized concerns about product recalls and violations of good manufacturing practices and MDR provisions. The agency also asked for input on how automatic external defibrillator performance levels can be validated and how their clinical reliability can be determined. FDA held a similar meeting in July with user groups, but it was closed to manufacturers ("The Gray Sheet" Aug. 15, p. 30)



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