CPG Sec. 335.800 Clinical Thermometer - Adulteration; Misbranding Defects

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CPG Sec. 335.800 Clinical Thermometer - Adulteration; Misbranding Defects
BACKGROUND:
The FDA has stated that NBS Commercial Standard CS 1-52, which became a Voluntary Product Standard
PS 39-70, would be used as the basis for regulatory action against clinical thermometers (mercury-in-
glass, reusable). The voluntary standard has now developed into an ASTM Standard E 667-81. The
following criteria reflect this updated material.
POLICY:
If clinical thermometers are found to be outside the specifications for accuracy as found in the ASTM E
667-81 Standard they will be considered to be violative.
REGULATORY ACTION GUIDANCE:
The following represents criteria for direct reference seizure to *the Office of Medical Device and
Radiological Health Operations (OMDRHO) with consult to* the Division of Enforcement, Office of
Enforcement and Import Operations, Office of Regulatory Affairs, Food and Drug Administration.
Sample Size Defects
15 2 or more
24 3 or more
A clinical thermometer is considered defective for accuracy if the following accuracy cannot be met.
(Round to one decimal place)
Celsius Scale Fahrenheit Scale
Less than 35.80C 0.30C Less than 96.40F 0.40F
35.80C to 37.00C 0.20C 96.40F to 98.00F 0.30F
37.00C to 39.00C 0.10C 98.00F to 102.00F 0.20F
39.00C to 41.00C 0.20C 102.00F to 10600F 0.30F
Greater than 41.00C 0.30C Greater than 106.00F 0.40F
SPECIMEN CHARGES:
That the article of device is adulterated when introduced into and while in interstate commerce within
the meaning of 21 U.S.C. 351(c) in that its quality falls below that which it purports or is represented to
possess.
That the article of device is misbranded when introduced into and while in interstate commerce (or after
receipt in interstate commerce if applicable) within the meaning of 21 U.S.C. 352(a) in that the label
statements "Accurate", "Dependable", "Easy Reading", and "*** this thermometer conforms to all of the
requirements established in ASTM Standard E 667-81" are false *or* misleading or are otherwise
contrary to fact.

*Material between asterisks is new or revised*
Issued: 1/1/73
Reissued: 10/1/80 7/18/94
Revised: 9/24/87, 3/95