An FDA Viewpoint on Unique Considerations for Medical-Device Clinical Trials

N Engl J Med. 2017 Apr 6;376(14):1350-1357. doi: 10.1056/NEJMra1512592.

Authors

Owen Faris¹, Jeffrey Shuren¹

Affiliation

¹ From the Center for Devices and Radiological Health, Food and Drug Administration, Silver Spring, MD.

PMID: 28379790
DOI: 10.1056/NEJMra1512592

No abstract available

Publication types

Review

MeSH terms

Clinical Trials as Topic* / methods
Clinical Trials as Topic* / standards
Device Approval*
Humans
Research Design / standards
United States
United States Food and Drug Administration*