First six Class II devices added to FDA's third-party review pilot.
This article was originally published in The Gray Sheet
Executive SummaryFIRST CLASS II DEVICES ADDED TO THIRD-PARTY REVIEW PILOT include transcutaneous electronic nerve stimulators (TENS), clinical electronic thermometers, and rheumatoid factor immunology tests. The six products also include condoms (with and without spermicide) and sterilizers greater than two cubic feet in size.
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