FDA Identifies 21 Devices as Candidates for Reclassification
In 2014, the U.S. Food and Drug Administration (FDA) reviewed 69 percent of medical device product codes subject to post-market approval (PMA) and identified 21 of them as candidates for...
View ArticleMedical Devices & FDA: Top 10 Tips for Marketing a Device in the USA
U.S. Food and Drug Administration (FDA) regulations for marketing medical devices in the United States are extensive and can be difficult to understand. Registrar Corp, an FDA consulting firm that...
View ArticleeMDR Compliance Date Less Than 2 Months Away
In February 2014, the U.S. Food and Drug Administration (FDA) published a final rule requiring medical device manufacturers and importers to submit mandatory initial and supplemental adverse event...
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