Medical Devices; Immunology and Microbiology Devices; Classification of the SARS-CoV-2 Serology Test
FDA reclassifies SARS-CoV-2 serology tests into class II with special controls. This does not directly affect cosmetics or MoCRA compliance.
Aforeworn detected this change in the Cosmetics & Personal-Care (MoCRA) space on July 6, 2026 and published this briefing so affected operators are forewarned rather than caught off guard. It is rated Low urgency. Cosmetics and personal care businesses (indie brands, contract manufacturers, private-label makers, importers/distributors) are not affected. should confirm how it applies to their specific situation before acting. There is a time constraint attached: N/A. Acting after that point can mean penalties, a lapsed licence, or lost eligibility — exactly the kind of surprise Aforeworn exists to prevent. Aforeworn monitors Cosmetics & Personal-Care (MoCRA) continuously and turns every detected change into a plain-English briefing like this one, so you always know first. Forewarned is forearmed.
What changed
FDA classification of SARS-CoV-2 serology tests; no change to cosmetics regulations.
Who it affects
Cosmetics and personal care businesses (indie brands, contract manufacturers, private-label makers, importers/distributors) are not affected.
What you must do
No action needed for cosmetics compliance.
Deadline
N/A
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