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Handbook
FDA Regulatory Pathways/Applications for
Investigational Medical DevicesPrepared by:
Sherry Seizes
Program Manager, Regulatory Affairs
States×salad.UNM.editable OF CONTENTS
INTRODUCTION
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What is fda regulatory pathwaysapplications for?
fda regulatory pathwaysapplications are used for obtaining regulatory approval for medical products.
Who is required to file fda regulatory pathwaysapplications for?
Manufacturers and distributors of medical products are required to file fda regulatory pathwaysapplications.
How to fill out fda regulatory pathwaysapplications for?
fda regulatory pathwaysapplications can be filled out online through the FDA's official website.
What is the purpose of fda regulatory pathwaysapplications for?
The purpose of fda regulatory pathwaysapplications is to ensure the safety and efficacy of medical products before they are marketed to the public.
What information must be reported on fda regulatory pathwaysapplications for?
Information such as product specifications, clinical trial data, manufacturing processes, and labeling must be reported on fda regulatory pathwaysapplications.
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