Well Isn’t that Special: An Assessment of the Special Control Associated with Simple Point of Care COVID-19 Antigen Tests
FDA Law Blog
MAY 19, 2023
Baumhardt, Senior Medical Device Regulation Expert & Richard A. Labeling Special Controls The labeling may seem like the easiest Special Control for demonstrating compliance. Here we have broken out the requirements for the Indications for Use, Quick Reference Instructional Sheet, and Device Labeling.
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