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FDA 510k Process for Medical Devices



 
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Product Code: WB3
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A 510(k) is a premarket submission made to the FDA to demonstrate that the device to be marketed is at least safe and effective. It provides a regulatory pathway for many products to enter the market by showing "substantial equivalence" to an already marketed product, typically without the need for clinical trials. This webinar will discuss the 510(k) process from an FDA perspective: When is a 510(k) necessary?;Review Process and considerations;FDA perspective on successful submissions.

Speaker:
Heather Rosecrans
Director of 510(k) Staff, Office of Device Evaluation/Center for Devices and Radiological Health
FDA

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