What You Need to Know About the FDA 510(k) Premarket Notification Process

So you want to get a new device on the market. How do you start the approval process? An FDA 510(k) (Food and Drug Administration) premarket notification grants you the ability to market your medical device in the United States. But before you can submit a notification, you have to know the class of your device because not all devices need to submit an FDA 510(k). (more…)

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