Clinical Electronic Thermometers That Are Not Currently 510(k) Cleared
- FDA has waived requirements for 510(k) Premarket Notification, reports of corrections and removals (21 CFR 806), registration and listing (21 CFR Part 807), and unique device identification (UDI) marking (21 CFR Part 830 and 801.20).
- Manufacturing must comply with 21 CFR Part 820, ISO 13485:2016 (Quality Management Systems), or equivalent quality system approach.
- Device must have marketing authorization in the regulatory jurisdictions for Europe (CE Mark), Australia, Canada, or Japan; otherwise, performance of device must conform to standards listed below, as applicable.
- Labeling must include a clear description of the available data on the device’s indications or function including: device performance, method of determining temperature, potential risks, and cleaning and reprocessing instructions.
- Labeling must include a clear identification the device is not FDA approved or cleared.
Thermometer (Performance) Standards
- ASTM E1104-98 (Reapproved 2016), Probe Covers and Sheaths
- ASTM E1965-98 (Reapproved 2016), Infrared Thermometer Patient Temperature
- ASTM E1112-00 (Reapproved 2011), Electronic Thermometer Patient Temperature
- ISO 80601-2-56 2nd Ed 2017-03, Body Temperature Measurement
- ASTM E825-98 (Reapproved 2016), Phase Change-Type Disposable Fever Thermometer
- ASTM E1061-01 (Reapproved 2014), Direct-Reading Liquid Crystal Forehead Thermometers
Electrical Standards (or ANSI/AAMI American Equivalent)
- ES60601-1:2005/(R2012) and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012, Electrical Safety
- IEC 60601-1-2:2014, EMC
- IEC 60601-1-11:2015, Home Healthcare
- IEC 62304:2006/A1:2016, Software Life Cycle
- ISO 10993-1, Biocompatibility
- ISO 10993-5:2009, Cytotoxicity
- ISO 10993-10:2010, Skin Sensitization & Irritation
Import information on Custom & Border Patrol website: CSMS #42124872 -Information for Filing Personal Protective Equipment and Medical Devices During COVID-19
Contact FDA to resolve entry issues:
- FDA’s Enforcement Policy classifies “Thermometers” as Clinical Electronic Thermometers (Product Code FLL, 880.2910) which are used to measure and monitor the body temperature of patients. The definition includes both contact and non-contact clinical electronic thermometers.
- The formal title of FDA’s enforcement policy is “Enforcement Policy for Clinical Electronic Thermometers During the COVID-19 Public Health Emergency: Guidance for Industry and FDA Staff” published published on April 3, 2020.
- FDA’s Enforcement Policy does not apply to previously 510(k)-cleared clinical thermometers.
- FDA encourages firms to discuss any alternatives to its performance and labeling recommendations with FDA. Inquiries should be made to email@example.com.