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Five Wound Dressing Categories Should Be Class I, 510(k) Exempt - HIMA

This article was originally published in The Gray Sheet

Executive Summary

The Health Industry Manufacturers Association is proposing that FDA designate five types of unclassified preamendments wound dressings as Class I devices exempt from 510(k) requirements.

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Wound dressing downclassification

Nonreabsorbable gauze/sponges for external use, hydrophilic wound dressings, occlusive wound dressings, and hydrogel wound dressings are downclassified to Class I, 510(k)-exempt status in an Oct. 4 final rule. The General and Plastic Surgery Devices Panel recommended the downclassification at a November 1998 meeting. The Health Industry Manufacturers Association had recommended that porcine wound dressings also be Class I, 510(k)-exempt (1"The Gray Sheet" Nov. 16, 1998, p. 8). FDA plans to address porcine wound dressing in the future. Some panel members had raised concerns about the potential risk for the transmission of infectious materials in wound dressings that are composed of materials derived of animal-based sources

QUOTED. 4 December. Eric Borin.

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