Neurosurgical materials and devices

Report on regulatory agencies and advisory groups

Restricted access

✓ The current status of voluntary consensus standards writing procedures in neurosurgery and the current progress of government efforts to regulate materials and devices are described. A survey of the national and international standards writing bodies is presented, along with an introduction to related organizations and agencies and nomenclature. The intent of this review is to provide the neurosurgeon with a reference source regarding past and present neurosurgical activities in the materials and devices field. When President Ford signed the 1976 Medical Device Amendments on May 28, 1976, the Food and Drug Administration assumed direct legal authority to control medical devices and potentially assumed the power to regulate those professionals using them.

Article Information

Present address for Joseph T. McFadden, M.D.: Neurosurgical Associates, 607 Medical Tower, Norfolk, Virginia 23507.

Address reprint requests to: Charles V. Burton, M.D., 2545 Chicago Avenue, Minneapolis, Minnesota 55404.

© AANS, except where prohibited by US copyright law.

Headings

References

  • 1.

    American National Standards Institute: Guide for the development of American national standards. Published by ANSI143 Broadway, New York, New YorkNovember1972American National Standards Institute: Guide for the development of American national standards. Published by ANSI 143 Broadway New York New York November 1972

    • Export Citation
  • 2.

    American Society for Testing and Materials: ASTM standards for surgical implants. Published by ASTM1916 Race Street, Philadelphia, PennsylvaniaJuly1973American Society for Testing and Materials: ASTM standards for surgical implants. Published by ASTM 1916 Race Street Philadelphia Pennsylvania July 1973

    • Export Citation
  • 3.

    American Society for Testing and Materials: The voluntary standard system of the U.S.A. Published by ASTM1916 Race Street, Philadelphia, PennsylvaniaApril1975American Society for Testing and Materials: The voluntary standard system of the U.S.A. Published by ASTM 1916 Race Street Philadelphia Pennsylvania April 1975

    • Export Citation
  • 4.

    Association for the Advancement of Medical Instrumentation: AAMI membership brochure. Published by AAMI1901 North Fort Meyer Drive, Arlington, Virginia1976Association for the Advancement of Medical Instrumentation: AAMI membership brochure. Published by AAMI 1901 North Fort Meyer Drive Arlington Virginia 1976

    • Export Citation
  • 5.

    International Organization for Standardization: IOS memento 1974. Published by IOSCase Postale 56, 1211 Geneva 20, Switzerland1974International Organization for Standardization: IOS memento 1974. Published by IOS Case Postale 56 1211 Geneva 20 Switzerland 1974

    • Export Citation
  • 6.

    National Technical Information Service: Medical devices: a legislative plan. Published by NTIS5285 Port Royal Road, Springfield, VirginiaSeptember1970National Technical Information Service: Medical devices: a legislative plan. Published by NTIS 5285 Port Royal Road Springfield Virginia September 1970

    • Export Citation
  • 7.

    U.S. Congress.House. A bill to amend the Federal Food, Drug and Cosmetic Act to provide for the safety and effectiveness of medical devices intended for human use. H.R. 554594th Congress, first sessionMarch 26, 1975U.S. Congress. House. A bill to amend the Federal Food Drug and Cosmetic Act to provide for the safety and effectiveness of medical devices intended for human use. H.R. 5545 94th Congress first session March 26 1975

    • Search Google Scholar
    • Export Citation
  • 8.

    U.S. Congress.House. A bill to amend the Federal Food, Drug and Cosmetic Act to provide for the safety and effectiveness of medical devices intended for human use, and other purposes. H.R. 1112494th Congress, first sessionDecember 11, 1975U.S. Congress. House. A bill to amend the Federal Food Drug and Cosmetic Act to provide for the safety and effectiveness of medical devices intended for human use and other purposes. H.R. 11124 94th Congress first session December 11 1975

    • Search Google Scholar
    • Export Citation
  • 9.

    U.S. Congress.House. Committee on Interstate and Foreign Commerce. Medical device legislation introduced in the 93rd Congress. Committee report no. 9August 1973U.S. Congress. House. Committee on Interstate and Foreign Commerce. Medical device legislation introduced in the 93rd Congress. Committee report no. 9 August 1973

    • Search Google Scholar
    • Export Citation
  • 10.

    U.S. Congress.Senate. An act to protect the public health by amending the Federal Food, Drug and Cosmetic Act to assure the safety and effectiveness of medical devices. S. 51094th Congress, first sessionApril 21, 1975U.S. Congress. Senate. An act to protect the public health by amending the Federal Food Drug and Cosmetic Act to assure the safety and effectiveness of medical devices. S. 510 94th Congress first session April 21 1975

    • Search Google Scholar
    • Export Citation
  • 11.

    U.S. Congress.Senate. Medical device amendments of 1973. Senate report no. 93-67093rd Congress, second sessionJanuary 29, 1974U.S. Congress. Senate. Medical device amendments of 1973. Senate report no. 93-670 93rd Congress second session January 29 1974

    • Search Google Scholar
    • Export Citation

Metrics

Metrics

All Time Past Year Past 30 Days
Abstract Views 68 68 7
Full Text Views 143 143 1
PDF Downloads 45 45 0
EPUB Downloads 0 0 0

PubMed

Google Scholar