Regulatory Developments December 2021

Table of Contents
Regulatory Developments
December 2021

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Learn about recent draft guidances as of November 2021.

GUIDANCES

Type Title Status Date

Premarket, 510(k)

Enforcement Policy for Viral Transport Media During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (Revised): Guidance for Commercial Manufacturers, Clinical Laboratories, and Food and Drug Administration Staff

Final

11/15/2021

CLIA (Clinical Laboratory Improvement Amendments), IVDs (In Vitro Diagnostic Devices), Immunology & Microbiology

Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised): Guidance for Developers and Food and Drug Administration Staff

Final

11/15/2021

Electronic Submissions

Center for Biologics Evaluation and Research

Final

11/12/2021

Premarket, Digital Health

Center for Devices and Radiological Health

Draft

11/04/2021




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If you or your AAPS Community would like to submit comments, please contact Maria Nadeau. She will coordinate your input on behalf of AAPS.