US Food and Drug Administration medical device review and approval; Myths, misconceptions, realities, and potential policy changes

2014 ◽  
Vol 4 (6) ◽  
pp. 472-478
Author(s):  
Paul E. Wallner ◽  
Howard M. Sandler
Keyword(s):  
Medical Device ◽  
Drug Administration ◽  
Food And Drug Administration ◽  
Policy Changes ◽  
Administration Medical

An analysis of food and drug administration medical device reports relating to total joint components

1997 ◽  
Vol 12 (7) ◽  
pp. 765-771 ◽  
Author(s):  
Frank P. Castro ◽  
George Chimento ◽  
Barry G. Munn ◽  
Richard S. Levy ◽  
Stephen Timon ◽  
...  
Keyword(s):  
Medical Device ◽  
Drug Administration ◽  
Food And Drug Administration ◽  
Administration Medical

scholarly journals The Food and Drug Administration Medical Device Review Process

Stroke ◽  
2005 ◽  
Vol 36 (2) ◽  
pp. 404-406 ◽  
Author(s):  
Richard P. Felten ◽  
Neil R.P. Ogden ◽  
Carlos Peña ◽  
Miriam C. Provost ◽  
Michael J. Schlosser ◽  
...  
Keyword(s):  
Medical Device ◽  
Drug Administration ◽  
Review Process ◽  
Food And Drug Administration ◽  
Administration Medical

Neurosurgical materials and devices

1976 ◽  
Vol 45 (3) ◽  
pp. 251-258 ◽  
Author(s):  
Charles V. Burton ◽  
Joseph T. McFadden
Keyword(s):  
Medical Device ◽  
Drug Administration ◽  
Medical Devices ◽  
Food And Drug Administration ◽  
International Standards ◽  
Current Status ◽  
Reference Source ◽  
Legal Authority ◽  
Content Type ◽  
Fine Print

✓ 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.

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