Drugs and Devices
The Â鶹ÊÓƵ/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 Â鶹ÊÓƵ 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.
- Neurosurgery Urges Congress to Fund Pediatric Device Consortia 05.06.24
- Neurosurgery Comment on Benefits of Registry Data for FDA Regulatory Purposes 02.20.24
- Neurosurgery Provides Recommendations for Updated CDC Pain Guideline 6.16.20
-
FDA Issues Aneurysm Safety Update
On Dec. 18, 2019, MicroVention released a 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
- Neurosurgery Summits Comments to Congress on Cures 2.0 Legislation 12.16.19
- Neurosurgery Calls on Congress to Repeal the Medical Device Tax 9.24.19
- Neurosurgery Sends Letter of Support for H.R. 2207, the Protect Medical Innovation Act
- Neurosurgery Sends Letter of Support for S. 692, the Protect Medical Innovation Act
- Neurosurgery Sends Comments to the Health Tax Taskforce Regarding the Medical Device Excise Tax 6.14.19
- Neurosurgery Comments on Countering the US Opioid Epidemic 5.22.19
- Neurosurgery Comments on FDA Draft Guidance for Brain Metastases 5.13.19
- Neurosurgery Responds to Interagency Pain Task Force Draft Report on Pain Management Best Practices 04.01.19
- Neurosurgery Comments on FDA De Novo Device Approval Pathway Regulation 3.7.19
- Neurosurgery Joins the Alliance in Sending Letter to the CMS Regarding Modernizing Part D Proposed Rule 1.25.19
- Neurosurgery Joins Specialty Societies in Letter to FDA Regarding Intrathecal Drug Delivery Systems for Chronic Pain Patients 12.13.18
- Neurosurgery and 140 Other Groups Urge Congress to Repeal the Medical Device Excise Tax 12.05.18
- Neurosurgery Joins the AMA in Sending Letter to CMS Regarding Open Payments Reporting Requirements 12.3.18
- 2019 Outpatient Prospective Payment System and Ambulatory Surgical Center Payment Side-by-Side Comparison (prepared by Hart Health Strategies) 11.18.18
- Neurosurgery Joins Other Groups to Urge Lawmakers to Include the Overdose Prevention and Patient Safety Act in the Final Opioid Agreement 9.18.18
- Neurosurgery Joins Other Medical Specialties to Request Lawmakers Include the Overdose Prevention and Patient Safety Act in the Final Opioid Agreement 9.18.18
- Neurosurgery Joins the AMA in Sending a Letter to CMS Regarding Step Therapy in Medicare Advantage 9.7.18
- Neurosurgery responds to FDA Medical Device Safety Plan 8.16.18
- AMA Opioid Task Force August Progress Report 8.9.18
- Neurosurgery Sends Letter of Support to Reps. Meadows and Renacci for H.R. 4482, the “Opioid Abuse Deterrence, Research, and Recovery Act” 3.27.18
- Neurosurgery Sends Letter to Senate Regarding H.R. 5311, CARA Act 3.20.18
- Neurosurgery Joins the Alliance in Sending a Letter to the House Ways and Means Committee in Response to the RFI Regarding the Opioid Crisis 3.15.18
- Neurosurgery Urges CMS to Implement Appropriate Medicare Part D Opioid Policy 3.5.18
- Neurosurgery Joins Other Neurovascular Societies in Statement to FDA on Devices for Aneurysm Treatment 3.1.18
- Neurosurgery Joins other Neurovascular Specialties for Presentation to FDA on Devices for Aneurysm Treatment 3.1.18
- Neurosurgery Sends letter to Senate Regarding S. 2456, CARA Act 2.28.18
- Neurosurgery Sends Letter to Sens. Hatch and Wyden Regarding Opioid Use 2.16.18
- Neurosurgery Sends Letter to FDA Regarding Regulatory Reform 2.5.18
- Neurosurgery Joins the Alliance in Sending Letter to the FDA on Regulatory Reduction 2.5.18
- Neurosurgery Joins the Alliance in Sending Comments to CMS Regarding the Medicare Advantage/Part D Proposed Rule 1.16.18
- Neurosurgery joins coalition in letter to House and Senate Leaders Urging Device Tax Repeal 11.16.17
- Neurosurgery Naloxone Fact Sheet 9.21.17
- Alliance Statement for the Record for Judiciary Constitution and Civil Justice Subcommittee Hearing on “Examining Ethical Responsibilities Regarding Attorney Advertising” 6.23.17
- Â鶹ÊÓƵ and CNS Join the Alliance in Sending Comments to Sens. Cassidy and Collins Regarding Health Reform 5.26.17
- Neurosurgery joins the Alliance in Sending Comments to Sen. Hatch Regarding Health Reform 5.23.17
- Â鶹ÊÓƵ and CNS Send Letter Regarding Health Reform to Sen. Hatch 5.22.17
- Neurosurgery Joins Alliance to Congratulate Scott Gottlieb, MD, on his Confirmation as Commissioner of the FDA 5.9.17
- Neurosurgery Joins Alliance in Sending Letter of Support to Rep. Griffith for H.R. 1703, the Medical Product Communications Act of 2017 5.2.17
- FDA Presentation Slides from Â鶹ÊÓƵ/CNS Drugs and Devices Committee Seminar 4.26.17
- Neurosurgery Sends Letter to Sens. Gillibrand and McCain Regarding the Opioid Addiction Prevention Act 4.18.17
- Neurosurgeon Adnan Siddiqui, MD Presentation to FDA on Embolic Protection Device 2.24.17
- Â鶹ÊÓƵ and CNS Statement on the Confirmation of Rep. Tom Price to Lead HHS 2.10.17
- PCRC Letter to Senate Leadership Supporting 21st Century Cures 12.01.16
- Neurosurgery Joins Other Medical Groups to Request Funds to Address the Opioid Epidemic 11.28.16
- Neurosurgery Comments at FDA Meeting on Off-label Use Communication 11.9.16
- Neurosurgery Sends 21st Century Cures Letter to Speaker Ryan 8.11.16
- Neurosurgery Joins Other Groups in Commending Congress for the Passage of the Comprehensive Addiction and Recovery Act (CARA) 7.14.16
- Neurosurgery Joins other Medical Groups in Sending Letter of Support to Sen. Barrasso for the Protect Continuing Physician Education and Patient Care Act 6.29.16
