[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR864.3260]

[Page 216]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES--(Continued)
 
PART 864--HEMATOLOGY AND PATHOLOGY DEVICES--Table of Contents
 
          Subpart D--Pathology Instrumentation and Accessories
 
Sec. 864.3260  OTC test sample collection systems for drugs of abuse testing.

    (a) Identification. An over-the-counter (OTC) test sample collection 
system for drugs of abuse testing is a device intended to: Collect 
biological specimens (such as hair, urine, sweat, or saliva), outside of 
a medical setting and not on order of a health care professional (e.g., 
in the home, insurance, sports, or workplace setting); maintain the 
integrity of such specimens during storage and transport in order that 
the matter contained therein can be tested in a laboratory for the 
presence of drugs of abuse or their metabolites; and provide access to 
test results and counseling. This section does not apply to collection, 
transport, or laboratory testing of biological specimens for the 
presence of drugs of abuse or their metabolites that is performed to 
develop evidence for law enforcement purposes.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification requirements in part 807, subpart E of 
this chapter subject to the limitations in Sec. 864.9 if it is sold, 
distributed, and used in accordance with the restrictions set forth in 
Sec. 809.40 of this chapter. If the device is not labeled or otherwise 
represented as sterile, it is exempt from the current good manufacturing 
practice regulations in part 820 of this chapter, with the exception of 
Sec. 820.198 of this chapter with respect to complaint files.

[65 FR 18234, Apr. 7, 2000]

    Effective Date Note: At 65 FR 18234, Apr. 7, 2000, Sec. 864.3260 was 
added to subpart D, effective Apr. 9, 2001. At 66 FR 17359, Mar. 30, 
2001, the effective date was delayed until June 8, 2001.