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MDUFMA device branding on hold

This article was originally published in The Gray Sheet

Executive Summary

Draft guidance entitled "1Compliance with Sec. 301 of the Medical Device User Fee & Modernization Act of 2002 - Identification of Manufacturer of Medical Devices" announcing FDA plans to exercise enforcement discretion and "not...object if a manufacturer has not fully implemented the changes required by Sec. 301" is posted June 19. The guidance, which includes a FAQ section affirms previous statements from staff conveying FDA's intent to give manufacturers an 18-month grace period to implement the MDUFMA provision once FDA issues final guidance on how to comply with Sec. 301 (2"The Gray Sheet" June 9, 2003, p. 9). MDUFMA Sec. 302, which requires reprocessors to label single-use devices with the reprocessor name, is outside the scope of the guidance and will be detailed in a separate guidance, FDA notes...

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