FDA to Exempt Certain Class II Clinical Thermometers From Pre-Market Notification Requirements
The FDA is exempting certain class II clinical thermometers from pre-market notification requirements, it said in a Federal Register notice. The order is effective June 18.
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The agency says this exemption "will decrease regulatory burdens on the medical device industry and will eliminate private costs and expenditures required to comply with Federal regulations." The FDA will amend classification language in the federal regulatory code to reflect this final determination, it continued.
The FDA said the exemption is for clinical electronic thermometers that have validated specifications and performance via appropriate testing and analysis, such as analysis and testing in accordance with FDA-recognized editions of standards as appropriate.