Hardware Podcasts

#376: FDA's Proposed Wound Dressing Rule: Industry Impacts and Regulatory Insights

Global Medical Device Podcast · 18 Jul 2024 · 39m · Episode 376

What this episode covers

Mark DuVal, President and CEO of DuVal & Associates, and Kathy Herzog, Senior Regulatory, Quality, and Compliance Associate at DuVal & Associates, critique the FDA's proposed rule to reclassify certain solid wound dressings, wound gels, and liquid wound washes. They argue the rule uses antimicrobial resistance (AMR) as a pretext to impose burdensome performance testing and remove existing marketing claims, creating a 'solution in search of a problem.' The guests highlight that the administrative record is thin, citing a 2016 panel where the FDA was voted down, and warn that the vague special controls will disproportionately harm small manufacturers while stifling innovation. They predict potential litigation and industry pushback, suggesting companies should engage with trade associations and prepare for regulatory challenges.

Most relevant to

established companies

Topics

Mentioned

Companies
Greenlight Guru, DuVal & Associates, FDA, Alliance of Wound Care Stakeholders, Washington Legal Foundation

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