[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: 21CFR864.3250]

[Page 215-216]
 
                        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. 864.3250  Specimen transport and storage container.

    (a) Identification. A specimen transport and storage container, 
which may be empty or prefilled, is a device intended to contain 
biological specimens, body waste, or body exudate during storage and 
transport in order that the matter contained therein can be destroyed or 
used effectively for diagnostic examination. If prefilled, the device 
contains a fixative solution or other general purpose reagent to 
preserve the condition of a biological specimen added to the container.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 864.9. 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. 820.180 of this chapter, with respect to general 
requirements concerning records, and Sec. 820.198 of this chapter, with 
respect to complaint files.

[54 FR 47206, Nov. 13, 1989, as amended at 65 FR 2310, Jan. 14, 2000]

[[Page 216]]


    Effective Date Note: At 65 FR 18234, Apr. 7, 2000, Sec. 864.3250 was 
amended by adding a sentence to the end of paragraph (a), effective Apr. 
9, 2001. At 66 FR 17359, Mar. 30, 2001, the effective date was delayed 
until June 8, 2001. For the convenience of the user, the added text is 
set forth as follows:

Sec. 864.3250  Specimen transport and storage containers.

    (a) * * * This section does not apply to specimen transport and 
storage containers that are intended for use as part of an over-the-
counter test sample collection system for drugs of abuse testing.

                                * * * * *