FDA's HCT/P enforcement-discretion period ended May 31, 2021. Before that date, the agency did not actively enforce certain requirements against HCT/P products, which gave companies time to determine whether a given product qualified for the section 361 pathway or needed to pursue drug or biologic approval.
That enforcement-discretion period ended May 31, 2021 and has not been renewed. Qualification under section 361 depends on all applicable criteria in 21 CFR 1271.10, and whether a specific intended use meets them is a determination for the clinic and its counsel.
The grace period is not current and has not been for several years. A vendor that frames its practices around a transitional or discretionary period is describing a window that already closed. Clinics should ask directly how a product is classified and documented today rather than relying on legacy assumptions about enforcement timing.
These products are not FDA approved or licensed for any disease or condition. Information is for licensed healthcare professionals and is not medical or legal advice.
Because the HCT/P enforcement discretion period ended in 2021, current vendor claims should be evaluated against today's compliance expectations, not a transitional grace period.