[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR870.1360]

[Page 305]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 870--CARDIOVASCULAR DEVICES--Table of Contents
 
              Subpart B--Cardiovascular Diagnostic Devices
 
Sec. 870.1360  Trace microsphere.

    (a) Identification. A trace microsphere is a radioactively tagged 
nonbiodegradable particle that is intended to be injected into an artery 
or vein and trapped in the capillary bed for the purpose of studying 
blood flow within or to an organ.
    (b) Classification. Class III (premarket approval).
    (c) Date PMA or notice of completion of a PDP is required. A PMA or 
notice of completion of a PDP is required to be filed with the Food and 
Drug Administration on or before December 26, 1996 for any trace 
microsphere that was in commercial distribution before May 28, 1976, or 
that has, on or before December 26, 1996 been found to be substantially 
equivalent to a trace microsphere that was in commercial distribution 
before May 28, 1976. Any other trace microsphere shall have an approved 
PMA or a declared completed PDP in effect before being placed in 
commercial distribution.

[45 FR 7907-7971, Feb. 5, 1980, as amended at 52 FR 17736, May 11, 1987; 
61 FR 50706, Sept. 27, 1996]