CDRH Cedes Regulatory Authority for Certain Wound Care Products to CBER

Posted 13 August 2013 | By Alexander Gaffney, RAC 

If you're the sponsor of a wound care product, you may soon be dealing with a new set of regulatory staff at the US Food and Drug Administration (FDA), the agency announced in the Federal Register on Tuesday.

The 13 August 2013 announcement explains that FDA is "transferring oversight responsibilities for certain wound care products" from the Center for Devices and Radiological Health (CDRH), where some new reside, to the Center for Biologics Evaluation and Research (CBER).

The wound care products in question are specifically those containing live cells. Those products are often used as skin substitutes when treating large wounds, such as burns or ones that might otherwise require skin grafts. The products are in many cases engineered into sheets of skin using bioengineered and other materials (such as fibers, which can act as scaffolding), explaining why FDA once regulated them more closely to medical devices.

However, FDA said it is now of the opinion that it makes more sense to regulate these products as biological entities, which are the purview of CBER (through the Center for Drug Evaluation and Research regulates many monoclonal antibodies).

"FDA believes that as more wound care products containing live cells are developed such consolidation is necessary for both efficient and consistent Agency action," it wrote in its Federal Register notice, released on 13 August 2013.

Affected products are those with the product codes MGR, PBD and OCE. FDA said six approved products will be affected by the move:

  • Apligra (#P950032, Organogenesis)
  • Transcyte Human Fibroblast-Derived Temporary Skin Substitute (P960007, Shire)
  • Dermagraft (P000036, Shire Regenerative Medicine)
  • Orcel Bilayered Cellular Matrix (P010016, Forticell BioScience)
  • Composite Cultured Skin (H990013, Ortec International)
  • Epicel Cultured Epidermal Autografts (H990002, Genzyme)

Most of the affected products also have a number of supplemental applications, which will also be affected by the Center change.

The new regulating authority will be CBER's Office of Cellular, Tissue and Gene Therapies, FDA explained, and will serve to "consolidate primary responsibility for regulating wound care products containing live cells in CBER."

New contact information will be available sometime in the near future on FDA's website, the agency added.


Federal Register

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