Surgical mask definition expanded
This article was originally published in The Gray Sheet
Executive Summary
1Surgical mask final 510(k) guidance clarifies that its scope includes "surgical masks" and "surgical N95 NIOSH certified respirators," following comments from 3M and University of Minnesota Industrial Hygiene Program Director Lisa Brosseau criticizing FDA's use of the term "N95 respirators." The March 5 guidance also incorporates changes based on Cardinal Health and Kimberly-Clark comments submitted in response to the May 2003 draft - a 1998 guidance FDA re-issued to formally solicit comments (2"The Gray Sheet" May 19, 2003, p. 17)...
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FDA MDUFMA stakeholder meeting: Year-end meeting for the week of Dec. 1 on the Medical Device User Fee & Modernization Act is being considered in lieu of a mid-year event, according to FDA staffers. The full-day December meeting likely will be held in the Washington, D.C. area. The agency initially had planned to hold a half-day meeting June 6, but chose to delay the date due to a conflict with the Medical Device Manufacturers Association's annual meeting (1"The Gray Sheet" May 5, 2003, In Brief)....MDUFMA billing update: FDA 2chart explaining payment instructions for normal payment, courier/delivery services and wire transfer procedures is posted May 15 on the agency's MDUFMA web page. Separately, 3CDRH MDUFMA billing contacts are listed May 13. General questions related to payment of 510(k) and PMA fees should be directed to Jim Norman, and general appeals questions should go to Bob Navazio. The Division of Small Manufacturers, International and Consumer Assistance will answer queries about small business fees and waivers...
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