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Early Communication with the FDA

Guidelines on FDA correspondence for manufacturers developing and marketing medical devices in the US

Coworkers attending meeting

The FDA is a huge organization, and whether you are a small start-up developing your first device or a large corporation expanding your products, it is common to be at a loss when communicating with the FDA. And let’s face it, sometimes it can be intimidating!

This paper is intended to provide guidelines, tips and other information to help you feel more confident when corresponding with the FDA to obtain information regarding the development and marketing of your medical device.

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