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.

• FDA Network of Experts Program
• FDA Neurological Devices Panel
• FDA Orthopaedic Devices Panel

• Neurosurgery Urges CMS to Ban Step Therapy in Medicare 06.01.22
• Neurosurgery Raises Concern with Consolidation of PBMs 05.17.22
• AANS/CNS Comment on Updated CDC Opioid Guidelines 04.04.22

• Neurosurgery Urges Congress to Fund Pediatric Device Consortium at FDA 11.08.21
• Neurosurgery Writes U.S. Attorney General re Intrathecal Pain Pumps & Controlled Substances Act 10.21.21
• Substance Use and Pain Care Task Force Releases New Recommendations 09.23.21
• Neurosurgery Provides Recommendations for Updated CDC Pain Guideline 6.16.20

• FDA Issues Aneurysm Safety Update

  On Dec. 18, 2019, MicroVention released a letter to health care providers with an update on reported adverse events for the MicroVention Woven EndoBridge (WEB) Aneurysm Embolization System. Specifically, six intra-procedural, intracranial aneurysm ruptures caused by aneurysm wall perforation were reported to MicroVention in 2019. These events resulted in patient deaths due to iatrogenic intra-procedural subarachnoid hemorrhage. The Food and Drug Administration (FDA) is asking neurosurgeons to take note of this information.

• Neurosurgery Comments on Medicare Opioid Prescribing Rules 04.06.20

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