Alliance Update: Third Quarter 2016 Policy News and Comments – Wound Dressing Classification & CTP Regulation
by The Alliance of Wound Care Stakeholders
The Alliance of Wound Care Stakeholders (Alliance) played a key role in educating the Food and Drug Administration (FDA) and its advisory panel on the role and real-world value of antimicrobial wound care dressings, as the FDA considered a regulatory classification of these products that could impact access and availability to wound care providers and patients.
FDA Panel Recommends Class II for Antimicrobial Wound Dressings
On September 20-21, the FDA convened its General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee regarding the classification of devices that are wound dressings combined with drugs. These products currently are classified under the "FRO" product code category and include but are not limited to: solid wound dressings, gels, creams, ointments, and liquid wound washes. FDA held the meeting to obtain input on the risks and benefits of wound dressings combined with drugs (antimicrobial wound dressings), and asked the panel for recommendations whether such wound dressings 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).
Though commonly used across a multitude of wound care applications, many antimicrobial wound dressings pre-date the FDA's classification system, so are currently unclassified. However, as FDA undertakes formal classification of these products, their designation could have a significant impact on the accessibility of these products by clinicians, the speed of bringing new wound dressing products to market, and the price of such products if they are determined by FDA to be Class III. As such, heading into the meeting, the Alliance took an active role in protecting access to this important category of wound care products by educating FDA and its advisory panel that the products in this FRO category are low to moderate risk, have been proven in the marketplace for many years, don't play a meaningful role in antibiotic resistance, and should be classified by the FDA into either Class I or Class II, most remaining subject to 510(k).
The Alliance took a three-prong advocacy approach to educate FDA and its panel: (1) submission of comments in advance of the meeting to provide relevant background information on wound care complexities, (2) submission of post-meeting follow-up comment (in progress, due Oct. 20), and (3) mobilization of a team of expert speakers to testify at the open public hearing portion of the meeting to proactively address issues that the panel needed to consider to make a well-informed decision. In addition to testimony from Alliance executive director Marcia Nusgart, speakers mobilized by the Alliance included:
- Dot Weir, on the management of chronic wounds
- Dr. Gregory Schultz, on the biology of wound healing
- Dr. Caroline Fife, on the value of wound care registries and registry data
- Dr. Marissa Carter, on trial design and endpoints
- Dr. Randall Wolcott, on clinical aspects of antimicrobial agents and antimicrobial resistance
- Dr. Susan Alpert, on classifying medical devices
- Dr. Eric Lullove, representing the Association for the Advancement of Wound Care
- Judy O'Grady, providing industry perspective from Integra LifeSciences
- Angela Bunn, providing industry perspective from Mölnlycke Healthcare
- Karen Ravitz, representing industry input from the Coalition of Wound Care Manufacturers
In its concluding votes, the advisory panel ultimately concurred with the Alliance's position, recommending to the FDA that antimicrobial wound dressings should be classified as a Class II with special controls. While the Agency is not obligated to follow the recommendations of its advisory committees, it does tend to.
The Alliance will be hosting a working session at the SAWC meeting in Las Vegas next week to debrief on this meeting and collect inputs for formal written comment submission. Contact Marcia Nusgart if you'd like to attend.
Alliance Weighs In as FDA Collects Input on the Regulation of HCT/Ps
Also in September, the FDA held a public hearing 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 from the 100+ registered speakers 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 as well as by the Coalition of Wound Care Manufacturers and other stakeholder groups. 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, provide a protective barrier and wound cover, and decrease the risk of bacterial contamination.
The draft FDA guidance documents have potential to help provide clarity regarding pathways forward for the development of additional innovative HCT/Ps, and promote the safe use of these products. However, the Alliance focused its testimony and written comments on specific areas of the "minimal manipulation" and "homologous use" guidances that need additional clarity to make them clinically meaningful, clinically accurate, and consistent with - rather than contradictory to - existing regulations.
"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 - represented by Dr. Paul Kim - informed the FDA in oral testimony, highlighting a number of specific examples: (1) the term "main function" introduced in the minimal manipulation document conflicts with the current definition of homologous use, and (2) the change regarding how minimal manipulation is determined - specifically the focus on the "main function" of the tissue in the donor rather than what is written in current law: by the function of the tissue in the recipient.
The Alliance and other commenters emphasized that the draft guidances in fact make material changes to current regulatory language, so should be subject to the notice-and-comment rule making process. It is unclear at this time whether the FDA will issue a proposed rule as a next step, or simply take some of the recommendations provided to them and revise the draft guidance documents. We'll track the issue and keep you informed.
About the Alliance of Wound Care Stakeholders
The Alliance of Wound Care Stakeholders: The Alliance is a nonprofit multidisciplinary trade association of health care professional and patient organizations whose mission is to promote quality care and access to products and services for people with wounds through effective advocacy and educational outreach in the regulatory, legislative, and public arenas.
The views and opinions expressed in this blog are solely those of the author, and do not represent the views of WoundSource, Kestrel Health Information, Inc., its affiliates, or subsidiary companies.