Drugs and Devices

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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
Letters

Neurosurgery Provides Recommendations for Updated CDC Pain Guideline

Published: June 16, 2020
Subject: Management of Acute and Chronic Pain Guideline. Docket No. CDC–2020–0029 Dear Dr. Redfield: The American Association of Neurological Surgeons (AANS) and the Congress of Neurological Surgeons(CNS) welcome the opportunity […]
  • Drugs and Devices
Letters

Neurosurgery Comments on Medicare Opioid Prescribing Rules

Published: April 6, 2020
Seema Verma, MPH, AdministratorCenters for Medicare & Medicaid ServicesU.S. Department of Health and Human ServicesHubert H. Humphrey Building, Room 445–G200 Independence Avenue, SWWashington, DC 20201 Submitted electronically via www.regulations.gov Subject: […]
  • Drugs and Devices
Letters

Neurosurgery Summits Comments to Congress on Cures 2.0 Legislation

Published: December 16, 2019
SUBJECT: Comments on Request for Feedback on Cures 2.0 Legislation Dear Reps. DeGette and Upton: On behalf of the American Association of Neurological Surgeons (AANS) and the Congress ofNeurological Surgeons […]
  • Drugs and Devices
Letters

Neurosurgery Calls on Congress to Repeal the Medical Device Tax

Published: September 24, 2019
Dear Majority Leader McConnell, Speaker Pelosi, Minority Leader Schumer and MinorityLeader McCarthy: On behalf of the over six hundred innovators, patient groups, physicians, hospitals, venturecapitalists and other stakeholders signed below […]
  • Drugs and Devices
  • Medical Liability Reform
Article

Neurosurgery Comments on Countering the US Opioid Epidemic

Published: May 22, 2019
American Association of Neurological Surgeons and Congress of Neurological SurgeonsCommitment on Countering the U.S. Opioid Epidemic The American Association of Neurological Surgeons (AANS), the Congress of Neurological Surgeons(CNS), and the […]
  • Drugs and Devices
Letters

Neurosurgery Comments on FDA Draft Guidance for Brain Metastases

Published: May 13, 2019
SUBJECT: FDA Draft Guidance for Industry on Cancer Clinical Trial Eligibility Criteria:Brain Metastases Dear Dr. Pazdur: On behalf of the American Association of Neurological Surgeons (AANS) and the Congress ofNeurological […]
  • Drugs and Devices
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