Post-Market Approval Surveillance-Reference-Cited by-同舟云学术

Post-Market Approval Surveillance

Published:2004-06-29 Issue:25 Volume:109 Page:3073-3077
ISSN:0009-7322
Container-title:Circulation
language:en
Short-container-title:Circulation

Author:

Mehran Roxana¹,Leon Martin B.¹,Feigal David A.¹,Jefferys David¹,Simons Michael¹,Chronos Nicholas¹,Fogarty Thomas J.¹,Kuntz Richard E.¹,Baim Donald S.¹,Kaplan Aaron V.¹

Affiliation:

1. From the Lenox Hill Heart and Vascular Institute, New York, NY (R.M., M.B.L.); Devices Sector, Medical Devices Agency-United Kingdom (D.J.); Cardiology Section, Dartmouth Medical School, Dartmouth-Hitchcock Medical Center, Lebanon, NH (A.V.K., M.S.); American Cardiovascular Research Institute (N.C.); Department of Surgery, Stanford University, Stanford, Calif (T.J.F.); and Department of Medicine, Brigham and Women’s Hospital, Boston, Mass (R.E.K., D.S.B.). Dr Feigal is the former Director of the...

Publisher

Ovid Technologies (Wolters Kluwer Health)

Subject

Physiology (medical),Cardiology and Cardiovascular Medicine

Link

https://www.ahajournals.org/doi/pdf/10.1161/01.CIR.0000134694.78653.B6

Reference22 articles.

1. 21 CFR §820 (2003).

2. United States General Accounting Office. Medical devices: Early warning of problems is hampered by severe underreporting. GAO/PEMD 87–1. Gaithersburg Md: US General Accounting Office; December 19 1986.

3. United States General Accounting Office. Medical devices: FDA’s implementation of the medical device reporting regulation. GAO/PEMD 89–10. Gaithersburg Md: US General Accounting Office; February 17 1989.

4. FDA Modernization Act of 1997 §519. Available at: http://www.fda.gov/opacom/laws/fdcact/fdctoc.htm. Accessed June 2 2004.

5. 21 CFR §803. Federal Register. December 11 1995.

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