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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.