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Specializing in FDA Regulatory Matters

Getting Your Medical Device Into the US Market

Prepared by Joe Ouellette, Independent Consultant EAS Consulting Group, LLC

September 26, 2017

The White Paper provides real-world and practical information directed to the manufacturer of Class II and Class III devices in navigating the Premarket Notification 510(k) clearance with insight into the various documentation required by FDA for submitting a 501(k). Getting a device ready for 510(k) submission is can be time-consuming, costly, full of challenges and EAS Independent Consultant Joseph Ouellette lays out the various requirements and suggestions for completing the forms in an expeditious and accurate manner. He also discusses some practical tips such as the development of a regulatory plan with a list of deliverables as well as anticipating questions FDA may ask throughout the process in order to successfully navigate the application process.

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