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    Little Known Facts About FDA's 510(k) Process

    Content provided by Emergo , a medical device regulatory affairs and quality assurance consulting firm with offices worldwide. In February, Emergo will release its annual analysis of FDA 510(k) review times for 2014 and prior years. During our analysis, we uncovered some interesting facts (at least to RA professionals) we wanted to share. For instance, did you know ... FDA has cleared more than 140,000 devices via the 510(k) program since 1976 FDA usually clea...