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This guidance describes FDA's RTA policy for premarket submissions submitted for cyber devices before October 1, 2023.

The U.S. Food and Drug Administration (FDA) has published updated draft guidance for industry, Electronic Systems, Electronic Records, and Electronic Signatures in Clinical...

Final guidance provides performance criteria for soft daily wear contact lenses (21 CFR 886.5925, LPL) in support of the Safety and Performance Based Pathway.

FDA developed this guidance document to outline general considerations for certain animal studies used to support device premarket submissions.

Clinical Trial Considerations to Support Accelerated Approval of Oncology Therapeutics

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Food and Drug Administration FDA issued updated draft guidance, Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations–Questions and Answers. Draft Guidance revamps earlier recommendations from 2017 regarding requirements of 21 CFR Part 11.

On March 15, 2023, the U.S. Food and Drug Administration (“FDA”) issued updated draft guidance, Electronic Systems, Electronic Records, and Electronic Signatures in Clinical...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.