BIOTRONIK, INC. INTERPRETATION OF MDR REQUIREMENTS WILL REMAIN UNCHANGED
This article was originally published in The Gray Sheet
Executive SummaryBIOTRONIK, 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."
You may also be interested in...
Submission surge in late 2019 means a spike in late summer 2020 user fee goals, including 16 novel agents in August alone.
Keeping Track: Approvals For Tazverik And Tepezza, Priority Reviews For Belantamab Mafodotin And Lynparza
The latest drug development news and highlights from our US FDA Performance Tracker.
Accelerated approval in epithelial sarcoma may de-risk the firm’s goals for approval of Tazverik in follicular lymphoma and other larger indications.