[Code of Federal Regulations]

[Title 21, Volume 8]

[Revised as of April 1, 2006]

From the U.S. Government Printing Office via GPO Access

[CITE: 21CFR809.30]



[Page 90-91]

 

                        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

    (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



[[Page 91]]



to patients and practitioners, e.g., forensic, academic, research, and 

other nonclinical laboratories.



[62 FR 62259, Nov. 21, 1997]