By The Alliance of Wound Care Stakeholders
The Alliance of Wound Care Stakeholders will be representing a united voice of wound care clinicians by submitting comments and providing oral comments at two important FDA public meetings in September that impact wound care providers, as well as manufacturers:
I. FDA's Sept 12-13 Meeting: Two-day public hearing for FDA to obtain input on four draft guidance documents relating to the regulation of human cells, tissues, and cellular and tissue-based products (HCT/Ps). See meeting agenda and Federal Register notice. FDA will consider information it obtains from the public hearing in the finalization of the four draft guidance documents:
- Minimal Manipulation of Human Cells, Tissues, and Cellular and Tissue-Based Products; Draft Guidance
- Homologous Use of Human Cells, Tissues, and Cellular and Tissue-Based Products; Draft Guidance
- Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) from Adipose Tissue: Regulatory Considerations; Draft Guidance for Industry
- Same Surgical Procedure Exception under 21 CFR 1271.15(b): Questions and Answers Regarding the Scope of the Exception; Draft Guidance
The Alliance has previously submitted comments on both the Minimal Manipulation and Homologous Use draft guidance, and will be augmenting its comments to these two guidances in oral testimony at this meeting, representing the united voice of leading wound care clinical organizations focused on promoting quality wound care, access to products and services for patients with wounds and the providers who treat them. The Alliance's testimony will be posted to the organization's website following the meeting
Note: FDA had originally announced its intention to collect inputs in a 1-day public hearing initially scheduled for April 13, 2016, but on February 29, 2016, announced that due to considerable interest in the public hearing and to give stakeholders additional time to provide comments to the Agency, the hearing was postponed. This September meeting is the new date for this meeting, and more than 100 speakers – including the Alliance and several of its member companies and organizations – are registered to provide oral comments.
II. 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 currently are classified under the "FRO" produce code category and include but are not limited to: 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.
Importantly, 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 of Wound Care Stakeholders has submitted initial comments to educate the Panel before the meeting stating: "The Alliance members believe that the products that are currently in the FRO category are low to moderate risk, have been in the marketplace for many years, and should be classified by the FDA into either Class I or Class II, most remaining subject to 510(k)."
The Alliance has organized its members to speak on the following issues at the upcoming meeting:
- Overview of wound care relating to the FRO product category
- Science behind management of chronic wounds
- Management of chronic wounds using antimicrobial wound care products
- Products classified in the FRO product category, their indications for use and testing
- Data supporting continuing safety and effectiveness of products in FRO category/ Low-moderate risk of antimicrobial resistance
- Trial design and published clinical evidence and guidelines
- Ongoing monitoring of the use of wound care products using registries
- Additional issues for FDA consideration
The Alliance will also be submitting comments after the meeting since the FDA docket will be open until October 20, 2016.
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.