FDA Frees Electronic Thermometers from Premarket Shackles
Published Date: 6/18/2025
Rule
Summary
The FDA just made it easier for companies that make certain clinical electronic thermometers by removing the need for a special premarket review. This change starts right away, cutting red tape and saving money for businesses. If you’re in the medical device world, this means faster, simpler steps to get these thermometers to market.
Analyzed Economic Effects
2 provisions identified: 2 benefits, 0 costs, 0 mixed.
510(k) Exemption for Clinical Thermometers
The FDA exempted certain Class II clinical electronic thermometers from the 510(k) premarket notification requirement. The exemption is immediately in effect and applies to those clinical electronic thermometers described in the order, subject to certain limitations.
Cuts Red Tape and Saves Businesses Money
FDA says this change will decrease regulatory burdens and eliminate private costs and expenditures required to comply with Federal regulations for the medical device industry. The Agency also says the change will make it faster and simpler for these thermometers to reach the market.
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Key Dates
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