The Medical Letter on Drugs and Therapeutics
FROM
ISSUE1268
ISSUE1268
Med Lett Drugs Ther. 2007 Aug 27;49(1268):72
Disclosures
Objective(s)
(Med Lett Drugs Ther 2007; 49:55) The second sentence in the article ("The FDA does not require proof of effectiveness for approval of devices with minimal potential for harm, such as this one.") should have been omitted. It would apply to a Class I device, but the FDA has classified Resperate as a Class II device.
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