Submitted Comments

Items Related to FDA

November 21, 2016

Comments to FDA's General & Plastic Surgery Devices Panel of the Medical Devices Advisory Committee supporting classification of antimicrobial wound care products as Class II with special controls.

The Alliance submitted detailed comments advocating that solid wound dressings combined with drugs that are formulated as cream, gel, or ointment, should be classified as Class II with special controls. The Alliance also expressed its agreement with the FDA's use of multiple product classification categories for antimicrobial products currently regulated in the FRO category (i.e., solids, cream/gel/ointment and liquid washes). The Alliance clarified that the wound care products in the FRO category containing such items as silver, PHMB, Cadexomer iodine and honey under discussion at the Panel meeting should be categorized as antiseptics and do not appear to contribute to antibiotic resistance. Comments clarified that antimicrobial wound care dressings are not intended to treat or heal the wound; instead the specific claims made in the labeling for these products include: maintain a moist wound environment, covers and protects the wounds, provides a barrier to penetration of microbes to the wound, which may reduce the risk of infection, etc.
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October 24, 2016

Comments to FDA draft guidance on "Use of Real World Evidence to Support Regulatory Decision-making for Medical Devices"

The Alliance submitted comments to the FDA on its draft guidance "Use of Real World Evidence to Support Regulatory Decision-making for Medical Devices." The Alliance voiced support for the use of data from registries, claims, and electronic health records when evaluating medical devices. Comments also addressed the limitations of randomized clinical trials in evaluating the effectiveness of a wound care product. The Alliance provided specific examples of how registry data could be used in assessing the safety of a wound care medical device.
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September 27, 2016

Comments to FDA draft guidance "Homologous Use of Human Cells, Tissues, and Cellular and Tissue-Based Products"

The Alliance submitted comments to the FDA draft guidance "Homologous Use of Human Cells, Tissues, and Cellular and Tissue-Based Products." Comments identified specific areas of the regulation that needed additional clarity and alignment across guidances in order to make them clinically meaningful, accurate, and consistent with - rather than contradictory to - existing regulations.
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September 27, 2016

Comments to FDA draft guidance "Minimal Manipulation of Human Cells, Tissues, and Cellular and Tissue-Based Products"

The Alliance submitted comments to the FDA on its "Minimal Manipulation of Human Cells, Tissues, and Cellular and Tissue-Based Products - draft guidances for industry and FDA staff." The Alliance highlighted a number of issues with regard to "main function" and "basic function" terminology in the guidance. Comments also identified multiple inconsistencies between the "Minimal Manipulation" guidance and the "Homologous Use" guidance. The Alliance encouraged the FDA should work with stakeholders to develop an appropriate guidance document that is consistent with guidances and current regulatory language and that provides needed clarity.
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September 12, 2016

Comments to FDA draft guidance "Minimal Manipulation of Human Cells, Tissues, and Cellular and Tissue-Based Products" (2)

The Alliance delivered oral comments at the FDA's September 2016 Public Hearing on Draft Guidances Relating to the Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products. The Alliance express concern with the narrow definition of homologous use of amnion tissue and how that will impact wound care, as there are many basic functions of amniotic tissue that should be used for wound healing. The Alliance noted that 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.
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September 1, 2016

Comments to FDA's General and Plastic Surgery Panel of the Medical Devices Advisory Committee

The Alliance submitted comments to the FDA's General and Plastic Surgery Panel of the Medical Devices Advisory Committee in advance of the panel's September 2016 meeting. The Alliance emphasized 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 comments gave perspective on the issue, addressing the following:

An overview of wound care relating to the FRO product category
The 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
Evidence for safety and effectiveness of products in FRO category/ Low-moderate risk of antimicrobial resistance

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February 23, 2015

- Comments to FDA Minimal Manipulation of Human Cell, Tissues, and Cellular, and Tissue-Based Products guidance document

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