Medical Device 513g Requests: FDA vs. FDAImports.com, The Battle Rages On
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April 20, 2012
Law & Regulatory, Medical Devices
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Tags: 510k, 513g, Battle, Costs, FDA, generic, medical device, non-binding, PMA, Request, type
FDA recently issued new guidance regarding how FDA responds to device classification questions submitted under Section 513(g) of the Federal Food, Drug, and Cosmetic Act. In short, a 513(g) Request for Information must be submitted in writing to FDA, must be for a single device, currently costs approximately $3,500 in (up front) user fees, and may take up to 60 days to process. So what does one get for all that time and money? In responding to … READ MORE
