Premarket notification or [[510(k)]] is a process by which a submitter notifies the FDA at least 90 days prior to the submitters inroduction of any appropriate device (some Class I and most Class II devices) into interstate commerce. The submission must include a product classification based on safety and effectiveness. Based on the information and the date submitted, the FDA determines whether the product is substantially equivalent to a legally marketed predicate device. When the FDA makes that finding, the submitter is notified and may market the device. These submissions are called [[510(k)]]s because the report submission requirement is identifies in the Act under this section number

See: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/default.htm
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fda_public
created
Sat, 23 Jun 2012 14:07:27 GMT
creator
dirkjan
modified
Sat, 23 Jun 2012 14:07:27 GMT
modifier
dirkjan
tags
FDA
Term
creator
dirkjan