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Notifying FDA of a permanent discontinuance or interruption in manufacturing of certain devices as required by section 506J of the FD&C Act

This guidance is intended to assist owners or operators of cosmetic product facilities that are subject to the requirements related to facility registration and responsible persons that are subject to the requirements related to cosmetic product listing under the Federal Food, Drug, and Cosmetic Act

COVID-19 guidance

Real-Time Oncology Review (RTOR) Draft Guidance for Industry

Submitting Clinical Trial Datasets and Documentation for Clinical Outcome Assessments Using Item Response Theory

This guidance explains why FDA may deny a Certificate to Foreign Government to device manufacturers, and how manufacturers can request a review of the denial.

Submitting Patient-Reported Outcome Data in Cancer Clinical Trials

The guidance describes policies that are intended to help foster compliance with certain applicable legal requirements for clinical electronic thermometers.

This guidance outlines FDA’s policies for certain limited modifications affecting the safety and effectiveness of devices approved through PMA or HDE.

The public can attend the meeting both in person and online.