Table 1:

Classification and regulatory pathways for approved diabetic wound products.

Product	Description	Classification	Regulatory pathway
TegasorbTM	Hydrocolloid dressing	Device	510 (K) pre-market notification
Hyalomatrix®	Hyaluronic acid derivative hydrogel	Device	510 (K) pre-market notification
Regranex®	Hydrogel with platelet derived growth factor	Drug	NDA
DermACELL®	Acellular human cadaver derived matrix	Device	HCT/P
ActicoatTM	Silver incorporated polymer matrix	Combination device, FRO	510 (K) pre-market notification