FDA Updates Template For Home COVID-19 Test Development
The US FDA’s most recent update is intended to help test makers provide validation data and other information to the agency for developing at-home diagnostic tests.
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FDA Targets Makers Of OTC COVID-19 Tests With Tweaks To 2 EUA Templates
The US agency made changes to two of its emergency use authorization templates “to support authorization of more COVID-19 tests” for over-the-counter use and to offer “flexible study recommendations.”
News We’re Watching – US FDA Updates, Digital Therapeutics Legislation, AI Endoscopies, Monkeypox EUA, And New AdvaMed Chair
The US Food and Drug Administration recently issued updates regarding improvements to its online submissions portal, enhancements to its electronic medical device reporting system, pediatric X-ray guidance, expanded indications for a popular breathing device, and mammogram guidelines; and more news we’re watching.
Defective Packaging Poses Risk To Joint Replacement Patients
The FDA is reminding patients and health care providers about some Exactech joint replacement devices due to how the devices were packaged.