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After successful FDA approval, what do you need to do next?
Автор: Medical Device Academy
Загружено: 2023-02-16
Просмотров: 404
Описание:
This week, instead of the usual Friday live-streaming YouTube video, our live-streaming was on Thursday morning: February 16, 2023 @ 7:15 am EST. Every Thursday, we host a webinar on preparing FDA 510k submissions using the new FDA eSTAR template as part of our 510k course. Sadly, we don’t discuss what you need to do after FDA 510k clearance. For example:
When do you need to register your company with the FDA?
Do you need a US Agent?
How far along does your quality system need to be?
When will the FDA conduct an inspection?
How do you get reimbursement for your device?
Who will help you with distribution and sales?
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