Category: 510(k)

Govzilla 510k 101

510(k) 101

The FDA 510(k) Program, also referred to as premarket notification, is an FDA marketing clearance application and is the most common avenue of premarket submission for medical devices. This article serves to provide you with a high-level understanding of the items required in 510(k) submissions and resources to help you during the process.

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New CDRH Guidance in October

by Barbara Unger, GMP Quality Expert, and GMP Regulatory Intelligence Editor-in-Chief The FDA has been on a bit of a tear in publishing guidance for

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