CLIA
This article was originally published in The Gray Sheet
Executive Summary
Comments are due within 30 days of the March 1 publication in the Federal Register of the Medical Devices Draft Guidance for Clinical Laboratory Improvement Amendments of 1988 Criteria for Waiver. The guidance includes an alternate path to waiver based on user comparability criteria, but also retains methods laid out in the 1995 proposed rule (1"The Gray Sheet" Jan. 29, 2001, p. 3)
You may also be interested in...
CLIA Guidance Allows Firms To Gain Waiver Through User Comparison Studies
Manufacturers seeking waived status for diagnostic tests under user-based criteria will need to perform agreement studies with at least 300 untrained users to show that those users obtain the same results as lab professionals, according to an FDA draft guidance issued Jan. 23.
Cosmetic And Personal Care Trademark Review: 16 April
Personal care and cosmetic product trademark filings compiled from the Official Gazette of the US Patent and Trademark Office, Class 3.
Health And Wellness Weekly Trademarks Review: 16 April
Trademarks are registered and published for opposition with the US Patent and Trademark Office and are published weekly in the agency's Official Gazette.