🌡️FDA Exempts Class II Clinical Electronic Thermometers from Regulations
Medical Devices; Exemptions From Premarket Notification: Class II Devices; Clinical Electronic Thermometers
Summary
The Food and Drug Administration (FDA, we, or the Agency) is publishing an order setting forth the Agency's final determination to exempt certain class II clinical electronic thermometers from premarket notification (510(k)) requirements, subject to certain limitations. This exemption from 510(k), subject to certain limitations, is immediately in effect for such class II clinical electronic thermometers. This exemption will decrease regulatory burdens on the medical device industry and will eliminate private costs and expenditures required to comply with Federal regulations. FDA is amending the classification language within the Code of Federal Regulations for certain class II clinical electronic thermometers to reflect this final determination. FDA is publishing this order in accordance with the Federal Food, Drug, and Cosmetic Act (FD&C Act).
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$ - Med
The FDA's exemption of certain Class II clinical electronic thermometers from premarket notification (510(k)) rules reduces regulatory burdens and compliance costs for manufacturers, which can enhance market entry and financial predictability.