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BIOTRONIK, INC. INTERPRETATION OF MDR REQUIREMENTS WILL REMAIN UNCHANGED

This article was originally published in The Gray Sheet

Executive Summary

BIOTRONIK, INC. INTERPRETATION OF MDR REQUIREMENTS WILL REMAIN UNCHANGED until FDA clarifies its policy on medical device reporting rules, company Vice President and General Manager Jake Langer says in a July 21 "preliminary response" to a recent warning letter. Biotronik says it believes its current procedures "correctly interpret the MDR regulation" and will change its approach "only upon clear instructions from" FDA's District Office in Bothell, Washington, "a response from Mr. [Bryan] Benesch [from the Division of Surveillance Systems in the device center's Office of Surveillance and Biometrics] to our inquiries, or a change in the MDR regulation."

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