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Letters

Neurosurgery Comments on FDA De Novo Device Approval Pathway Regulation

Published: March 17, 2019
Subject: Docket FDA-2018-N-0236 Proposed Rule: Medical Device De NovoClassification Process. Dear Dr. Gottlieb, The American Association of Neurological Surgeons (AANS) and the Congress of Neurological Surgeons(CNS) appreciate the opportunity to […]
  • Drugs and Devices