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Surgical Mask 510(k) Guidance Outlines Performance Data Recommendations

This article was originally published in The Gray Sheet

Executive Summary

FDA is working with other federal agencies "to coordinate the regulation of" respirators that include surgical mask claims, the agency says in a recent draft guidance document.

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Regulatory News In Brief

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...

APACMed 2020: Healthineers Evolves Therapy Remit And Makes All Asia An Equal Priority

Siemens Healthineers' product mix of diagnostics and imaging products meant it was in the middle of a very dynamic situation when COVID-19 struck.

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