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Sourav Patnaik

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Special 510(k)

Posted By Sourav Patnaik 14-May-2020 03:46
Found In Egroup: RAPS Twin Cities Chapter \ view thread
If a manufacturer is interested to get a clearance for a labeling change from Rx to OTC can this be done through a special 510(k)? This is the only change that is being done to the device which was cleared earlier by the FDA for home use and there are absolutely no design changes that are being done ...