PBDHumanitarian device exemption

Composite Cultured Skin

21 CFR 878.4024 / General, Plastic Surgery

PBD is the FDA product code for Composite Cultured Skin, regulated under 21 CFR 878.4024. FDA's definition for this code reads: "For patients with mitten hand deformities due to Recessive Dystrophic Epidermolysis Bullosa (RDEB)". As of 2026-09-10, FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code: PBD
Device name: Composite Cultured Skin
FDA definition: For patients with mitten hand deformities due to Recessive Dystrophic Epidermolysis Bullosa (RDEB)
Regulation: 21 CFR 878.4024
Device class: Humanitarian device exemption
Review panel: General, Plastic Surgery
Submission type: FDA code 6
Implant: Yes
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 0
Ingested recalls: 0

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code PBD.

Recent clearances

Product code PBD

FDA records hold no clearances under product code PBD.

Recent recalls

Product code PBD

FDA records show no recalls under product code PBD.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)