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Sec. 301 branding provisions on chopping block?

This article was originally published in The Gray Sheet

Executive Summary

Oct. 29, the Senate HELP Committee's last scheduled mark-up date, may provide OEMs with their final opportunity this year to secure technical corrections to MDUFMA clarifying that inclusion of a manufacturer's name, abbreviation or symbol should apply only to single-use device reprocessors, not to OEMs. Without the legislative fix, advocated in several industry comments to FDA, the agency will be hard pressed to develop branding guidance, according to CDRH staffers. In June, FDA released a 1draft guidance indicating an 18-month grace period would be attached to the final guidance release date (2"The Gray Sheet" June 23, 2003, In Brief)...

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