| |
| | Legal Concerns with Proposed Jurisdictional Changes to Combination Wound Repair Products Containing Live Cellular ... |
 | | Both manufacturers of cellular wound repair products and independent researchers testified that cellular wound repair products are by structure and function single entity products, not clearly divisible, and applied as a whole to a designated wound site. |
 | | Cellular wound repair products, thus, are not "analogous" to a virus, therapeutic serum, or toxin or antitoxin, respectively. |
 | | This separate regulatory framework for cellular and tissue products, in our view, is yet another indication that Section 351 has important limitations, and that any approval/license requirements would apply only to the extent that structural cellular products otherwise meet the existing statutory definitions of drug, device, or biological product. |
| www.fda.gov /oc/combination/advamed8202002.html (6468 words) |
|