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Biomaterials legislation

This article was originally published in The Gray Sheet

Executive Summary

The Health Industry Manufacturers Association is planning to propose legislation designed to keep firms from exiting the biomaterials supply business, HIMA president Alan Magazine said at a March 30 session of the association's annual meeting. HIMA says the proposal will suggest "tort reform" for cases involving materials used in medical devices. The HIMA initiative was prompted by announcements by Dow Corning and DuPont that they will cease supplying materials for medical implants. HIMA says it is concerned that additional materials suppliers also may withdraw from the medical device market. FDA has set up a system intended to expedite review of substitute materials for Dow Corning's implant-grade silicone ("The Gray Sheet" March 15, I&W-1). However, some implant firms believe that high-quality substitute materials may not be currently available.

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