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.
- Neurosurgery Provides Recommendations for Updated CDC Pain Guideline 6.16.20
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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
- 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- Neurosurgery Comments on FDA Draft Guidance for Brain Metastases 5.13.19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
- AANS 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
- AANS 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 AANS/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
- AANS/CNS Urge Neurosurgeons to Promote Safe Storage and Disposal of Opioids 4.17.17
- Neurosurgery Joins the Alliance to Support Scott Gottlieb, MD for FDA Commissioner 3.31.17
- Alliance Position Statement on Physician-Directed Applications 3.17.17
- Neurosurgeon Adnan Siddiqui, MD, Presentation to FDA on Embolic Protection Device 2.24.17
- Neurosurgery Joins Alliance of Specialty Medicine to Create 2017 Health Policy Principles 2.21.17
- Neurosurgery Joins Alliance in Sending Letter to Senate Leadership Supporting 21st Century Cures 12.1.16
- PCRC Letter to Senate Leadership Supporting 21st Century Cures 12.01.16
- AANS and CNS Send Letter Urging House to Pass 21st Century Cures 11.29.16
- 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
- AANS and CNS Support FDA Classification of Posterior Cervical Screws 6.8.16
- AANS and CNS Comment on Draft FDA Guidance on Investigational Device Exceptions (IDEs) for Neurological Devices 6.6.16
- AANS and CNS Sign on to Reducing Opioid Abuse Advertisement 05.18.16
- Neurosurgery Joins AMA Task Force on Reduce Opioid Abuse Advertisement 05.18.16
- Neurosurgery Endorses the "Removing Barriers to Clinical Research Act" 12.11.15
- AANS/CNS Joint Section on Cerebrovascular Neurosurgery Provides Feedback to FDA Regarding Stroke Devices Public Workshop 11.30.15
- AANS and CNS Letter to Judiciary Committee Supporting Medical Controlled Substances Transportation Act 10.15.15
- AANS and CNS Letter to Committee on Energy and Commerce Supporting Medical Controlled Substances Transportation Act 10.15.15
- Summary of 2015-2017 Meaningful Use (MU) Final Rule 10.19.15
- Meaningful Use (MU) Stage 3 and 2015 Certification Rules 10.19.15
- Summary of Medicare and Medicaid EHR Incentive Program: Stage 3 and Modifications to Meaningful Use (MU) in 2015 and 2017 10.19.15
- AANS and CNS Letter Supporting Medical Controlled Substances Transportation Act 10.15.15
- Neurosurgery Joins Alliance in Sending Letter of Support for H.R. 6, the 21st Century Cures Act 7.9.15
- Neurosurgery Sends Letter to FDA Regarding Physician Directed Applications 6.29.15
- AANS and CNS Urge Congress to Repeal Medical Device Tax 6.16.15
- AANS and CNS Urge Ways and Means Committee to Pass H.R. 160, the “Protect Medical Innovation Act.” 6.1.15
- Neurosurgery Joins AMA in Sending Letter of Support for H.R. 293 to Rep. Burgess 5.29.15
- Senate Finance Health Subcommittee Holds Critical Hearing on Medical Device Tax 4.23.15
- Neurosurgery Sends Letter to NGA Urging for Increased Focus on Overdose Prevention and Treatment 2.19.15
- Neurosurgeons Join AdvaMed in Urging Congress to Repeal the Medical Device Tax 1.13.15
- AANS and CNS Unveil 2015 Legislative Agenda
- Neurosurgery Urges CMS to Maintain the Current Open Payments CME Exemption 9.2.14
- AANS and CNS Join Alliance to Comment on CMS Physician Sunshine Open Payment Implementation 7.28.14
- Neurosurgery Joins Partners for a Healthy Dialogue to Comment on CMS Physician Sunshine Act Implementation 7.28.14
- Instructions for Accessing CMS Physician Open Payments (Sunshine Act) Data 7.23.14
- AANS and CNS Send Letter to CMS Regarding Sunshine Act 6.2.14
- Neurosurgery Joins Alliance to Send Letter to FDA on Off-Label 5.2.14
- Alliance of Specialty Medicine Position Statement on Off-Label 5.2.14
- AANS/CNS Letter to DEA on Hydrocodone Reclassification 4.23.14
- AANS/CNS Sponsor Ad Urging Congress to Repeal Medical Device Tax 3.31.14
- AANS and CNS Unveil 2014 Legislative Agenda 3.18.14
- AANS-CNS Position Statement on Hydrocodone
- Sunshine Act (aka Open Payments) FAQs 9.14.13
- AANS/CNS Letter to FDA Regarding Reclassification of Pedicle Screw Systems 5-22-13
- AANS/CNS Statement to FDA Neurological Devices Panel on Neurostimulation for Epilepsy
- Letter to Senator Murkowski discussing the Medicare Patient Empowerment Act
- AANS/CNS 2013 Legislative Agenda
