Comments to FDA Proposed Classification of Certain Wound Dressings/Requirement for PMAs

In comments submitted to the FDA's proposed rule on classification of certain wound dressings and the accompanying requirements for premarket approval applications, the Coalition flagged the many "gaps and ambiguities" in the current policy, the reduced availability of wound dressing products that could result, and the harm this could cause to wound management and patient outcomes. Given these significant concerns, the Coalition requested that the Agency withdraw the policy for futher vetting. "Limiting access to these products could lead clinicians to prescribe more systemic antibiotics, which will adversely affect antibiotic resistance and stewardship initiatives. Furthermore, if FDA wants to proceed, in addition to the impact analysis, we request that it publish a new proposed classification rule and companion guidance with details regarding special controls and test standards that are currently lacking, estimates of the true cost of the proposed rule so as to ensure currently marketed products stay on the market with their current indications and without the need to submit new 510(k)s," the Coalition wrote. 

See Coalition Comments