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What to Know About De Novo
What is De Novo? The De Novo classification request provides a pathway to classify novel devices ...
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OUR SERVICES
510(k) Submissions
De Novo Classification
Premarket Approval
In Vitro Diagnostic Devices
US FDA Form 483 & Warning Letters
Medical Device Regulation
Periodic Safety Update Reports
In Vitro Diagnostic Regulation
EUDAMED Database
QUALITY ASSURANCE
RESOURCES
BLOG
VIDEOS & PODCASTS
ABOUT
OUR TEAM
CAREERS
EVENTS
CONTACT