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

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2024-07-18
- Length: 39m
- Episode: 376
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-07-18-376-fdas-proposed-wound-dressing-rule-industry-impacts-and-regulatory-insights
- Listen: https://podcast.greenlight.guru/episode/376-fdas-proposed-wound-dressing-rule-industry-impacts-and-regulatory-insights

## Summary

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.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-07-18-376-fdas-proposed-wound-dressing-rule-industry-impacts-and-regulatory-insights#t=0) Introduction: Greenlight Guru QMS and Episode Overview
- [1:59](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-07-18-376-fdas-proposed-wound-dressing-rule-industry-impacts-and-regulatory-insights#t=119) Mark DuVal on the Broad Implications and AMR Pretext
- [5:32](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-07-18-376-fdas-proposed-wound-dressing-rule-industry-impacts-and-regulatory-insights#t=332) Kathy Herzog on 40 Years of Safety and Thin Administrative Record
- [8:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-07-18-376-fdas-proposed-wound-dressing-rule-industry-impacts-and-regulatory-insights#t=480) Industry Response, Litigation Threats, and Economic Rationale
- [14:33](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-07-18-376-fdas-proposed-wound-dressing-rule-industry-impacts-and-regulatory-insights#t=873) Impact on Small Manufacturers and Vague Special Controls
- [19:23](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-07-18-376-fdas-proposed-wound-dressing-rule-industry-impacts-and-regulatory-insights#t=1163) Broader FDA Overreach and Precedent Setting
- [25:04](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-07-18-376-fdas-proposed-wound-dressing-rule-industry-impacts-and-regulatory-insights#t=1504) Strategies for Companies: Defend Status Quo or Comply
- [29:41](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-07-18-376-fdas-proposed-wound-dressing-rule-industry-impacts-and-regulatory-insights#t=1781) Specific Examples of New Testing Requirements for Submissions
- [35:44](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-07-18-376-fdas-proposed-wound-dressing-rule-industry-impacts-and-regulatory-insights#t=2144) Parallel with LDTs and Future Regulatory Trends

## Topics

- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Intellectual property](https://hardwarepodcasts.com/topic/intellectual-property)
- [Policy, trade & tariffs](https://hardwarepodcasts.com/topic/policy-trade-and-tariffs)

## Most relevant to

established companies

## Mentioned

- Greenlight Guru (company)
- DuVal & Associates (company)
- FDA (company)
- Alliance of Wound Care Stakeholders (company)
- Washington Legal Foundation (company)

## Related episodes from other shows

- [056 - "Non-Promotional Compliance" with Darshan Kulkarni](https://hardwarepodcasts.com/podcast/lets-combinate/2022-10-26-056-non-promotional-compliance-with-darshan-kulkarni) (Let's Combinate)
- [135 - Combination Products Mindset, MDUFA and Combination Products, FDA Hierarchy, Supplier Management, Surprises in Industry, and Culture with Tony Watson](https://hardwarepodcasts.com/podcast/lets-combinate/2024-05-08-135-combination-products-mindset-mdufa-and-combination-products-fda-hierarchy-su) (Let's Combinate)

## Citing this page

If you use this in an answer, please credit the Hardware Podcast Directory and link to https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-07-18-376-fdas-proposed-wound-dressing-rule-industry-impacts-and-regulatory-insights. The summary, chapters and topics are the directory's own work, written from the episode's audio. The episode itself, its title and its audio belong to Global Medical Device Podcast.