To amend the Federal Food, Drug, and Cosmetic Act with respect to CLIA waiver study design guidance for in vitro diagnostics.

Bill: 114-hr-2443
Sponsor: full_name: Rep. Guthrie, Brett [R-KY-2]
Introduced: 2015-05-19
Policy area: Health
Subjects: Administrative law and regulatory procedures

Department of Health and Human Services

Drug safety, medical device, and laboratory regulation
Latest action: action_date: 2015-05-22
text: Referred to the Subcommittee on Health.

Summaries:
action_date: 2015-05-19
action_desc: Introduced in House
text: <p>This bill requires the Department of Health and Human Services to publish guidance that revises &ldquo;Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices&rdquo; and includes guidance on using comparable performance between types of users to demonstrate the accuracy of a medical device.</p>

tv_txt: I 114th CONGRESS 1st Session H. R. 2443 IN THE HOUSE OF REPRESENTATIVES May 19, 2015 Mr. Guthrie introduced the following bill; which was referred to the Committee on Energy and Commerce A BILL To amend the Federal Food, Drug, and Cosmetic Act with respect to CLIA waiver study design guidance for in vitro diagnostics.

1. CLIA waiver study design guidance for in vitro diagnostics (a) Draft revised guidance Not later than 12 months after the date of the enactment of this Act, the Secretary of Health and Human Services shall publish a draft guidance that— (1) revises section V Demonstrating Insignificant Risk of an Erroneous Result— Accuracy of the guidance entitled Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices and dated January 30, 2008; and (2) includes guidance on the appropriate use of comparable performance between a waived user and a moderately complex laboratory user to demonstrate accuracy. (b) Final revised guidance The Secretary of Health and Human Services shall finalize the draft guidance published under subsection (a) not later than 12 months after the comment period for such draft guidance closes.