February 27, 2024
In comments submitted to the FDA's proposed rule on classification of certain wound dressings and companion amendments, the Alliance requested that the Agency withdraw the policy for further vetting. Alliance comments flagged the many "gaps and ambiguities" in the current policy, the reduced availability of wound dressing products that could result if the policy is implemented and the harm this could cause to patient care. "Though we agree with FDA that creating a classification regulation may provide added benefits regarding regulatory expectations, we believe the current proposal will create much greater confusion about requirements for wound dressings, and result in the unnecessary withdrawal of many important products from the market to the detriment of clinicians and their patients. These regulatory actions may result in clinicians using more antibiotic products, exacerbating the very resistance problems that FDA is trying to address through regulations on antiseptic-based wound dressings and washes. Therefore, the Alliance respectfully requests that FDA withdraw its current proposal, and if it desires to proceed, we ask that it publish a more detailed proposed rule, with companion guidance, addressing the points raised stakeholder comments," the Alliance wrote.

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