Webinar for Special 510(k) Submissions

This webinar discusses what exactly a Special 510(k) is as well as to how your design plan should be different for a Special 510(k) submission. Other questions to be answered are:

Can you change your indications for use from your predicate device?

Do you have to utilize a predicate device?

What does the Special 510(k) RTA checklist look like?

Can your first 510(k) be a special 510(k)?

Do technology changes from a predicate device affect Special 510(k) status?

Can the FDA convert my Special 510(k) Submission into a Traditional 510(k)?

Do you need assistance with a new or current 510(k) Submission?
To learn more about the process or to speak with us about our consultation services please visit it us at www.medicaldeviceacademy.com or email at [email protected]

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