Dirkjan: Created page with "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 (..."

2020-08-25T07:19:47Z

Created page with "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 (..."

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Premarket notification or [[510(k)|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)|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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Premarket notification - Revision history

Dirkjan: Created page with "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 (..."