How To Classify Your New Medical Device For Fda Approval Summary


Recap of the Required Documentation for Medical Devices For Premarket Notification

A premarket notification or 510(k) is a collection of documentation that establishes substantial equivalence to an existing medical device. The FDA does not provide regulatory writers with a 510(k) form to complete but rather guidance documents. The content in these guidance documents helps writers put together a package in a format called a 510(k). Most […]

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How to Classify Your New Medical Device for FDA Approval Summary

  Medical device manufacturers looking to distribute medical devices in the US are required to register their medical devices with the FDA. The registration process for medical devices differs based on the risk of the device. There are three classifications of medical devices: class I, class II, and class III. Based on the device’s classification, […]

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