Description
This compliance policy guide describes FDA’s policy on when FDA considers clinical thermometers to be misbranded.
Key Topics
Terms and concepts identified from this document
Scope & Applicability
Product Classes
1Clinical Thermometer
Mercury-in-glass, reusable thermometers used as the subject of the guidance.
Regulatory Context
Regulatory Activities
1Seizure
Anticipated legal action under section 304 of the FD&C Act
Attributes
2Fahrenheit Scale
Measurement scale for accuracy testing.
Celsius Scale
Measurement scale for accuracy testing.
Standards & References
External Standards
3Voluntary Product Standard PS 39-70
Successor to NBS CS 1-52.
NBS Commercial Standard CS 1-52
Original standard used as the basis for regulatory action.
ASTM E 667-81
Standard for clinical thermometers used as the basis for regulatory action.
Specifications
1Accuracy Specifications
Criteria for Celsius and Fahrenheit scales that thermometers must meet.
See Also (8)
- CPG Sec. 350.100 Packaging Technologies and Tamper-Resistant Packaging Requirements for Contact Lens Solutions and Tablets
- CPG Sec. 325.100 Karaya Gum Powder and Related Devices for Use by Ostomates
- CPG Sec. 345.200 Diaphragms - Rx Devices
- CPG Sec. 300.600 Commercial Distribution with Regard to Premarket Notification (Section 510(k))
- CPG Sec. 320.100 Ear Piercing Devices
- CPG Sec. 300.100 Inspection of Manufacturers of Device Components
- CPG Sec. 398.450 Applicability of Positive Beam Limitation (PBL) Requirements When PBL is Provided on "Other than Stationary General Purpose" Radiographic System
- CPG Sec. 315.100 Illegal Interstate Commercial Shipment of Dentures (CPG retitled and revised 5/19/2005)