Response to the Proposed Food and Drug Administration Regulation of Laboratory-Developed Tests: It Is Past Time for Professional Consensus-Reference-Cited by-同舟云学术

Response to the Proposed Food and Drug Administration Regulation of Laboratory-Developed Tests: It Is Past Time for Professional Consensus

Published:2016-09-01 Issue:2 Volume:1 Page:239-241
ISSN:2576-9456
Container-title:The Journal of Applied Laboratory Medicine
language:en
Short-container-title:

Author:

Konnick Eric Q¹

Affiliation:

1. Department of Laboratory Medicine, University of Washington Medical Center, Seattle, WA

Publisher

Oxford University Press (OUP)

Subject

General Medicine

Link

https://academic.oup.com/jalm/article-pdf/1/2/239/42352880/1_1_2_239.pdf

Reference4 articles.

1. Food and Drug Administration. Draft guidance for industry, food and drug administration staff, and clinical laboratories: Framework for regulatory oversight of laboratory developed tests. http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm416685.pdf (Accessed 18 June 2016).

2. Maintaining life-saving testing for patients with infectious diseases: Infectious Diseases Society of America, American Society for Microbiology, and Pan American Society for Clinical Virology Recommendations on the Regulation of Laboratory-developed Tests;Caliendo;Clin Infect Dis,2016

3. The FDA and genomic tests: getting regulation right;Evans;N Engl J Med,2015

4. Food and Drug Administration. The public health evidence for FDA oversight of laboratory developed tests: 20 case studies. http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/UCM472777.pdf (Accessed 16 June 2016).

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