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

AANS and CNS Urge Congress to Repeal Medical Device Tax

Published: June 16, 2015
Subject: H.R. 160, the Protect Medical Innovation Act Dear Speaker Boehner and Leader Pelosi, On behalf of the American Association of Neurological Surgeons (AANS) and the Congress of NeurologicalSurgeons (CNS), […]
  • Drugs and Devices
Letters

AANS and CNS Send Letter to CMS Regarding Sunshine Act

Published: June 2, 2014
Re: Agency Information Collection Activities: Submission for OMB Review; CommentRequest [Document Identifier: CMS–10495] Dear Ms. Tavenner: On behalf of the American Association of Neurological Surgeons (AANS) and the Congress ofNeurological […]
  • Drugs and Devices
  • Medical Liability Reform
Letters

Neurosurgery Joins Alliance to Send Letter to FDA on Off-Label

Published: May 2, 2014
Re: Revised Draft Guidance for Industry: Distributing Scientific and Medical Publications onUnapproved New Uses – Recommended Practices Dear Assistant Commissioner Kux: The Alliance of Specialty Medicine (Alliance) is a coalition […]
  • Drugs and Devices
Article

Alliance of Specialty Medicine Position Statement on Off-Label

Published: May 2, 2014
Physician-Directed Applications A Position Statement of the Alliance of Specialty Medicine Physician-Directed Applications Physician-directed applications, also known as “off-label” 1 uses, are an integralcomponent of the art and science of […]
  • Drugs and Devices
Letters

Letter to Senator Murkowski discussing the Medicare Patient Empowerment Act

Published: February 8, 2013
RE: Support of S. 236, the “Medicare Patient Empowerment Act” Dear Senator Murkowski: As the Alliance of Specialty Medicine (Alliance), our mission is to advocate for soundfederal health care policy […]
  • Drugs and Devices
  • Emergency/Trauma Care and Stroke
  • Graduate Medical Education
Article

AANS/CNS 2013 Legislative Agenda

Published: January 1, 2013
REFORMING THE REFORM ABOLISH THE INDEPENDENT PAYMENT ADVISORY BOARD (IPAB)Established by the Patient Protection and Affordable Care Act (ACA), the IPAB is a 15-member government board whosemembers are appointed by […]
  • Drugs and Devices
  • Emergency/Trauma Care and Stroke
  • Graduate Medical Education
Letters

A letter to the Food and Drug Administration regarding posterior cervical screws

Published: August 28, 2012
RE: Classification of posterior cervical screws, including pedicle and lateralmass screws [Docket No. FDA–2012–N–0001] FDA Orthopaedic andRehabilitation Devices Panel of the Medical Devices Advisory Committee Dear Ms. Anderson: The American […]
  • Drugs and Devices
  • Medical Liability Reform