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Neurosurgery Comments on FDA De Novo Device Approval Pathway Regulation

Last updated: April 24, 2025
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