Medical Devices; Clinical Chemistry and Toxicology Devices; Classification of the Prognostic Test for Development or Progression of Preeclampsia
FDA classifies prognostic test for preeclampsia into class II, but this is a medical device regulation, not directly impacting cosmetics under MoCRA. No immediate action required for cosmetics businesses.
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 by this medical device classification. 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 classified a prognostic test for preeclampsia as class II medical device; no changes to MoCRA requirements.
Who it affects
Cosmetics and personal-care businesses (indie brands, contract manufacturers, private-label makers, importers/distributors) are not affected by this medical device classification.
What you must do
No action needed for cosmetics compliance.
Deadline
N/A
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