Humanitarian Use Devices/Humanitarian Device Exemptions in Cardiovascular Medicine-Reference-Cited by-同舟云学术

Humanitarian Use Devices/Humanitarian Device Exemptions in Cardiovascular Medicine

Published:2005-11 Issue:18 Volume:112 Page:2883-2886
ISSN:0009-7322
Container-title:Circulation
language:en
Short-container-title:Circulation

Author:

Kaplan Aaron V.¹,Harvey Elisa D.¹,Kuntz Richard E.¹,Shiran Hadas¹,Robb John F.¹,Fitzgerald Peter¹

Affiliation:

1. From the Cardiology Section, Dartmouth Medical School and Dartmouth-Hitchcock Medical Center, Lebanon, NH (A.V.K., H.S., J.F.R.); Centers for Devices and Radiologic Health, US Food and Drug Administration, Rockville, Md (E.D.H.); Department of Medicine, Brigham and Women’s Hospital, Boston, Mass (R.E.K.); and Cardiovascular Medicine Section, Stanford University, Stanford, Calif (P.F.).

Publisher

Ovid Technologies (Wolters Kluwer Health)

Subject

Physiology (medical),Cardiology and Cardiovascular Medicine

Reference12 articles.

1. Medical Device Development

2. Post Safe Medical Devices Act (SMDA) of 1990 Public Law 91-4243.

3. 21 CFR 814 subpart H.

4. Snider S. Fetal stent receives first “humanitarian use” approval. HHS News. US Department of Health and Human Services February 14 1997. Available at: http://www.fda.gov/bbs/topics/NEWS/NEW00556.html. Accessed January 15 2005.

5. Section 520(m) Food Drug and Cosmetic Act.

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