Regulatory identity — United States
This document is technical information about materials. It does not recommend any procedure or product.
Regulatory identity by market
How are ECM-active materials regulated in United States?
Of the 15 materials in this atlas, 6 could be classified in United States from public sources — 5 as medical devices, 1 as drugs. The remaining 9 could not be established and are marked as such rather than inferred.
How each material in this atlas is classified in United States, with the legal basis where a classification could be established.
| Material | Classification | Note | Basis |
|---|---|---|---|
| Animal-derived collagen | medical-device | Animal-derived collagen dermal implants hold FDA premarket approval under PMA P800022, listed with the generic name 'implant, dermal, for aesthetic use'. The earliest approval found is dated 1981, the earliest record listed under that generic name. | Legal text |
| Botulinum toxin type A | drug | Licensed as a prescription biologic under BLA 103000, with marketing status recorded as prescription. This is the drug pathway, not the device pathway used by the fillers and biostimulators in this reference. | Legal text |
| CaHA (Calcium hydroxylapatite) | medical-device | Injectable CaHA implants hold FDA premarket approval under PMA P050037, listed with the generic name 'implant, dermal, for aesthetic use'. The earliest approval found is dated December 2006. This is the same generic name under which PLLA and crosslinked hyaluronic acid are listed. | Legal text |
| Crosslinked HA (Crosslinked hyaluronic acid) | medical-device | Crosslinked hyaluronic acid dermal implants hold FDA premarket approval, listed with the generic name 'implant, dermal, for aesthetic use'. The earliest record found dates from December 2003 under PMA P020023. | Legal text |
| Exosomes (Extracellular vesicles) | unclassified | Not established from public sources as of the revision date below. Cell-derived preparations may fall under the human cells and tissues framework rather than the device or cosmetic categories, and the classification depends on the specific product and its claims. | — |
| hADM (Human acellular dermal matrix) | unclassified | Human cells, tissues, and cellular and tissue-based products are regulated under 21 CFR Part 1271, again a separate pathway from the device and drug classifications used elsewhere in this table. | Legal text |
| Non-crosslinked HA (Non-crosslinked hyaluronic acid) | unclassified | Not established from public sources as of the revision date below. The dermal implant approvals found in the agency device database are for crosslinked products; no equivalent record was found for a non-crosslinked preparation. | — |
| PCL (Polycaprolactone) | unclassified | As of the revision date below, the full set of FDA premarket approval records listed under the generic name 'implant, dermal, for aesthetic use' was reviewed (22 distinct approvals), and a polycaprolactone dermal implant was not found in that list. Listing through a route outside this generic name cannot be ruled out, so this is left unestablished. | — |
| PDLLA (Poly-D,L-lactic acid) | unclassified | As of the revision date below, the full set of FDA premarket approval records listed under the generic name 'implant, dermal, for aesthetic use' was reviewed (22 distinct approvals), and a PDLLA dermal implant was not found in that list. Listing through a route outside this generic name cannot be ruled out, so this is left unestablished. | — |
| PDO (Polydioxanone) | medical-device | Absorbable polydioxanone sutures are listed as devices cleared through the 510(k) premarket notification pathway (for example K063680, 2007). What was verified is the suture indication; listings for individual aesthetic thread products were not established. | Legal text |
| PDRN (Polydeoxyribonucleotide) | unclassified | Public sources distinguish topical products marketed as cosmetics from injectable use, which is described as not FDA-approved. A single material-level classification could not be established as of the revision date below. | — |
| PLGA (Poly(lactic-co-glycolic acid)) | unclassified | As of the revision date below, the full set of FDA premarket approval records listed under the generic name 'implant, dermal, for aesthetic use' was reviewed (22 distinct approvals), and a PLGA dermal implant was not found in that list. Listing through a route outside this generic name cannot be ruled out, so this is left unestablished. | — |
| PLLA (Poly-L-lactic acid) | medical-device | An injectable PLLA dermal implant holds FDA premarket approval under PMA P030050, listed with the generic name 'implant, dermal, for aesthetic use'. This is the device pathway, not the drug pathway. | Legal text |
| PN (Polynucleotide) | unclassified | Not established from public sources as of the revision date below. | — |
| rhCollagen (Recombinant human collagen) | unclassified | As of the revision date below, the full set of FDA premarket approval records listed under the generic name 'implant, dermal, for aesthetic use' was reviewed (22 distinct approvals), and a recombinant human collagen dermal implant was not found in that list. Listing through a route outside this generic name cannot be ruled out, so this is left unestablished. | — |
COS cosmetic · MD medical device · RX drug · — not established in public sources