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
Never miss a change like this again
Aforeworn watches Cosmetics & Personal-Care (MoCRA) around the clock and alerts you the moment a rule moves — with a plain-English brief on what to do.
Start your free trialRelated changes in Cosmetics & Personal-Care (MoCRA)
- New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Application; Change of Sponsor
- New Jersey bans some products with toxic PFAS chemicals. Here’s what to know - WHYY
- Implementing MoCRA: FDA Releases New Draft Guidances on Insanitary Conditions for Tattoo Ink and Cosmetic Product Registration & Listing - Food and Drug Law Institute (FDLI)
- France bans PFAS in cosmetics – COSlaw.eu - Guiding through EU Cosmetics Regulations - COSlaw.eu
- Illinois Governor Signs Bill Banning Intentionally Added PFAS in Certain Consumer Products and Requiring IEPA to Prepare Report on Fluoropolymers by August 1, 2027 - Bergeson & Campbell