[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR809.30]

[Page 97-98]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 809_IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE--
Table of Contents
 
         Subpart C_Requirements for Manufacturers and Producers
 
Sec. 809.30  Restrictions on the sale, distribution and use of analyte specific reagents.

    (a) Analyte specific reagents (ASR's) (Sec. 864.4020 of this 
chapter) are restricted devices under section 520(e) of the Federal 
Food, Drugs, and Cosmetic Act (the act) subject to the restrictions set 
forth in this section.
    (b) ASR's may only be sold to:
    (1) In vitro diagnostic manufacturers;
    (2) Clinical laboratories regulated under the Clinical Laboratory 
Improvement Amendments of 1988 (CLIA), as qualified to perform high 
complexity testing under 42 CFR part 493 or clinical laboratories 
regulated under VHA Directive 1106 (available from Department of 
Veterans Affairs, Veterans Health Administration, Washington, DC 20420); 
and
    (3) Organizations that use the reagents to make tests for purposes 
other than providing diagnostic information to patients and 
practitioners, e.g., forensic, academic, research, and other nonclinical 
laboratories.
    (c) ASR's must be labeled in accordance with Sec. 809.10(e).
    (d) Advertising and promotional materials for ASR's:
    (1) Shall include the identity and purity (including source and 
method of acquisition) of the analyte specific reagent and the identity 
of the analyte;
    (2) Shall include the statement for class I exempt ASR's: ``Analyte 
Specific Reagent. Analytical and performance characteristics are not 
established'';
    (3) Shall include the statement for class II or III ASR's: ``Analyte 
Specific Reagent. Except as a component of the approved/cleared test 
(name of approved/cleared test), analytical and performance 
characteristics are not established''; and

[[Page 98]]

    (4) Shall not make any statement regarding analytical or clinical 
performance.
    (e) The laboratory that develops an in-house test using the ASR 
shall inform the ordering person of the test result by appending to the 
test report the statement: ``This test was developed and its performance 
characteristics determined by (Laboratory Name). It has not been cleared 
or approved by the U.S. Food and Drug Administration.'' This statement 
would not be applicable or required when test results are generated 
using the test that was cleared or approved in conjunction with review 
of the class II or III ASR.
    (f) Ordering in-house tests that are developed using analyte 
specific reagents is limited under section 520(e) of the act to 
physicians and other persons authorized by applicable State law to order 
such tests.
    (g) The restrictions in paragraphs (c) through (f) of this section 
do not apply when reagents that otherwise meet the analyte specific 
reagent definition are sold to:
    (1) In vitro diagnostic manufacturers; or
    (2) Organizations that use the reagents to make tests for purposes 
other than providing diagnostic information to patients and 
practitioners, e.g., forensic, academic, research, and other nonclinical 
laboratories.

[62 FR 62259, Nov. 21, 1997]