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 Coalition submitted comments to FDA’s General & Plastic Surgery Devices Panel of the Medical Devices Advisory Committee on FDA-2016-N-2147, recommending that antimicrobial wound care dressings in the FRO category, such as solids, cream/gel/ointment and liquid washes, be classified as Class II medical devices and regulated using the 510(k) premarket notification process. The Coalition based this recommendation on the fact that antimicrobial products in the FRO category fit the safety and effectiveness standards for class II while falling short of the standards for class III.
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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Comments to FDA draft guidance “Homologous Use of Human Cells, Tissues, and Cellular and Tissue-Based Products”

The Coalition submitted comments to the FDA on their draft guidance on the Homologous Use of Human Cells, Tissues, and Cellular and Tissue-Based Products, FDA-2015-D-3581, stating that despite a few concerns with the clarity of the FDA guidance document, the Coalition supports the FDA’s choices of terminology revolving around human cell and tissue products (HCT-Ps). The Coalition outlines concerns, however, with the FDA’s draft guidance on homologous uses for amnion tissue and the FDAs perception of “manufacturer objective intent.” The Coalition also addresses evidentiary and clarification concerns throughout the regulation.
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September 1, 2016

Comments to FDA’s General and Plastic Surgery Panel of the Medical Devices Advisory Committee for its Sept. 20-21 Meeting

The Coalition submitted comments to the FDA’s General and Plastic Surgery Panel of the Medical Devices Advisory Committee on FDA-2016-N-2147, stating that FRO products in the class II category should require 510(k) clearance and special controls to ensure their safety and effectiveness. The Coalition also advocated for the FDA establishing sub-categories within the FRO classification, outlining what these categories may include. Finally, the Coalition recommended a re-establishment of the safety and efficacy of products in the FRO category.
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September 1, 2016

Testimony at FDA's Public Hearing on Draft Guidances Relating to the Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products

The Coalition provided oral testimony at the FDA's Public Hearing on Draft Guidances Relating to the Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products (CTPs), acknowledging many FDA recommendations that the Coalition agrees with regarding minimal manipulation and homologous use. However, the Coalition also outlined issues with the process the FDA uses in issuing guidance documents. This process, argues the Collation, would benefit from significantly increased stakeholder input. Furthermore, the Coalition recommends that the FDA go through an appropriate regulatory process when they wish to make substantive changes within a given guidance document.
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February 23, 2015

Comments to FDA on “Minimal Manipulation of Human Cells, Tissues, and Tissue-Based Products”

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May 9, 2011

Coalition comments on FDA Medical Device Repository