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This guidance describes FDA's general recommendations for the transition process with respect to devices issued EUAs during the COVID-19 pandemic.
This guidance describes FDA’s general recommendations for a phased transition for devices that fall within enforcement policies issued during the COVID-19 PHE.
Food and Drug Administration FDA issued updated draft guidance, Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations–Questions and Answers. Draft Guidance revamps earlier recommendations from 2017 regarding requirements of 21 CFR Part 11.
On March 15, 2023, the U.S. Food and Drug Administration (“FDA”) issued updated draft guidance, Electronic Systems, Electronic Records, and Electronic Signatures in Clinical...
Understand how and when FDA imposes a no-tobacco-sale order (NTSO) and how FDA determines the length of an NTSO.