Alliance of Wound Care Stakeholders Update

Comments (oral testimony) were submitted to FDA by the Alliance of Wound Care Stakeholders at the Agency’s public hearing (Sept. 12-13) to obtain input on its four draft guidance documents relating to the regulation of human cells, tissues, and cellular and tissue-based products (HCT/Ps). While much of the public testimony focused on issues related to the more controversial area of stem cell therapies, the implications of these guidance documents for wound care were addressed by the Alliance, Coalition of Wound Care Manufacturers and other stakeholder groups in attendance. HCT/Ps are of particular benefit to chronic non-healing wounds as they help provide an environment for the patient’s own cells to rebuild tissues.  In wound applications, HCT/Ps, because they are not significantly changed from native donor tissue (i.e. minimally manipulated), provide a protective barrier and wound cover which helps maintain a moist wound bed, and decrease the risk of bacterial contamination, which are key to allowing proper wound healing.

• The draft FDA guidance documents may help to provide pathways forward for the development of additional innovative HCTPs, and promote the safe use of these products.
• The Alliance focused comments on areas that needed additional clarity and alignment across guidances to make them clinically meaningful, clinically accurate, and consistent with – rather than contradictory to - with existing regulations. Of the 4 guidance documents under discussion, comments focused on the Minimal Manipulation and Homologous Use guidances that specifically impact wound care applications. “There are many significant new requirements within the minimal manipulation document which not only conflict with the homologous use document, they conflict with current regulatory language,” the Alliance informed the FDA, noting a number of specific example throughout its comments.   

FYI: Coming up next week: FDA’s Sept 20-21 Meeting

• The General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee will meet to discuss and obtain recommendations about the classification of devices that are wound dressings combined with drugs. These products include solid wound dressings, gels, creams, ointments, and liquid wound washes. FDA is holding this panel meeting to obtain input on the risks and benefits of wound dressings that are combined with drugs as well as the clinical relevance of certain indications. the Panel will be asked to recommend to FDA whether such wound dressings that are combined with drugs should be classified into Class III (subject to Premarket Approval), Class II (subject to General and Special Controls), or Class I (subject only to General Controls). A change in categorization (these are currently a Class II) would have a significant impact to the manufacturers who develop and market these important antimicrobial products, on the speed of new wound dressing products to market, the accessibility of these products by clinicians and potentially on the price of such products. The Alliance submitted comments in advance, and will be providing oral testimony at this meeting as well. 
  
  
  The full text of Alliance oral testimony at the FDA public meeting on its HCT/P guidances can be found here.