scholarly journals Food and Drug Administration (FDA) Medical Device Reports From 1991 to 2015: Are Radiation Oncology Devices Different?

2016 ◽  
Vol 96 (2) ◽  
pp. E394
Author(s):  
M. Connor ◽  
D.C. Marshall ◽  
R. Karunamuni ◽  
K.L. Moore ◽  
T. Pawlicki ◽  
...  
Keyword(s):  
Medical Device ◽  
Drug Administration ◽  
Radiation Oncology ◽  
Food And Drug Administration

scholarly journals US Food and Drug Administration Regulation of Medical Devices and Radiation Oncology: Can Reform Improve Safety?

2012 ◽  
Vol 8 (1) ◽  
pp. 53-56 ◽  
Author(s):  
Jona A. Hattangadi ◽  
James T. O'Reilly ◽  
Abram Recht
Keyword(s):  
Medical Device ◽  
Drug Administration ◽  
Medical Devices ◽  
Radiation Oncology ◽  
Food And Drug Administration ◽  
Regulatory Framework ◽  
General Review ◽  
Medical Device Regulation

A review of the issues involved in medical device regulation in radiation oncology, including a general review of federal medical device regulation and explanations of the legal and regulatory framework.

scholarly journals Medical Device Recalls in Radiation Oncology: Analysis of US Food and Drug Administration Data, 2002-2015

2017 ◽  
Vol 98 (2) ◽  
pp. 438-446 ◽  
Author(s):  
Michael J. Connor ◽  
Kathryn Tringale ◽  
Vitali Moiseenko ◽  
Deborah C. Marshall ◽  
Kevin Moore ◽  
...  
Keyword(s):  
Medical Device ◽  
Drug Administration ◽  
Radiation Oncology ◽  
Food And Drug Administration

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

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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