Regulations.gov document

Policy for Diagnostics Testing in Laboratories Certified To Perform High Complexity…

Notice · FDA-2020-D-0987 · posted Mar 6, 2020

Key facts

Document ID FDA-2020-D-0987-0008
Title Policy for Diagnostics Testing in Laboratories Certified To Perform High Complexity Testing Under the Clinical Laboratory Improvement Amendments Prior to Emergency Use Authorization for Coronavirus Disease-2019 During the Public Health Emergency; Immediately in Effect Guidance for Clinical Laboratories and Food and Drug Administration Staff; Availability
Document type Notice
Subtype Notice of Availability
Agency FDA
Docket FDA-2020-D-0987
Posted Mar 6, 2020
Federal Register citation 85 FR 13169
FR document number 2020-04630
Comment period opens Mar 6, 2020
Effective date Mar 6, 2020

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