[Congressional Bills 114th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2443 Introduced in House (IH)]

114th CONGRESS
  1st Session
                                H. R. 2443

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


_______________________________________________________________________


                    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.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 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Services shall publish a draft guidance that--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Services shall finalize the draft guidance published under subsection 
(a) not later than 12 months after the comment period for such draft 
guidance closes.
                                 <all>