Drugs and Devices

The AANS/CNS Drugs and Devices Committee is actively engaged with the Food and Drug Administration (FDA) and other scientific, governmental, clinical and industry representatives to provide neurosurgical expertise on drugs, devices and biologics used to treat patients and to foster innovation and patient safety. These activities include recommending neurosurgeon experts to serve on the FDA Advisory panels, providing input on FDA Guidance Documents and testimony at panel meetings, as appropriate. In addition, organized neurosurgery is an official partner with the FDA's Network of Experts program to provide rapid clinical assistance to FDA reviewers. The AANS and CNS continue to advocate policies that will decrease the regulatory burden for medical-device innovation and ensure patient access to new and improved medical technology.

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Letters

Neurosurgery Responds to FDA Regarding Adverse Event Reporting

Published: March 18, 2025
JonnaLynn CapezzutoOffice of OperationsU.S. Food and Drug AdministrationThree White Flint North, 10A–12M11601 Landsdown St.,North Bethesda, MD 20852 Subject: Food and Drug Administration (FDA) Adverse Event and Product Experience Reporting Program […]
  • Drugs and Devices
Letters

Neurosurgery Joins Coalition in Commenting on FDA Off-Label Guidance

Published: December 21, 2023
Lauren K. RothAssociate Commissioner for PolicyFood and Drug Administration5630 Fishers Lane, Rm. 1061Rockville, MD 20852 Submitted electronically via regulations.gov Re: Communications From Firms to Health Care Providers Regarding Scientific Information […]
  • Drugs and Devices
Medicare Advantage Data

Neurosurgery Urges CMS to Ban Step Therapy in Medicare

Published: June 1, 2022
The Honorable Chiquita Brooks-LaSure AdministratorCenters for Medicare and Medicaid ServicesDepartment of Health and Human Services7500 Security BoulevardBaltimore, MD 21244-1850 Via Electronic Delivery Re: Step Therapy for Part B Drugs in […]
  • Drugs and Devices
Letters

Neurosurgery Raises Concern with Consolidation of PBMs

Published: May 17, 2022
RE: Solicitation for Public Comments on the Business Practices of Pharmacy Benefit Managers and Their Impact on Independent Pharmacies and Consumers (FTC-2022-0015-0001) To Whom It May Concern: The Alliance of […]
  • Drugs and Devices
Letters

AANS/CNS Comment on Updated CDC Opioid Guidelines

Published: April 4, 2022
Angela K. Oliver, Executive SecretaryCenters for Disease Control and PreventionNational Center for Injury Prevention and Control4770 Buford Highway NEAtlanta, GA 30341 Attn: Docket No. CDC-2022-0024 Subject: Feedback on the CDC […]
  • Drugs and Devices
Letters

Neurosurgery Urges Congress to Fund Pediatric Device Consortium at FDA

Published: November 8, 2021
Dear Chairwoman Baldwin, Chairman Bishop, Ranking Member Hoeven, and Ranking MemberFortenberry: On behalf of the 20 undersigned organizations, we write to thank you for your long-standing support ofthe Pediatric Device […]
  • Drugs and Devices