How to Get to get FDA Approval to Market a Medical Device
How to Get to get FDA Approval to Market a Medical Device
Determine the classification of your medical device.
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Search regulation for your device after you find out the device panel on CFR or Code of Federal Regulation Title 21.
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Find out if you can get FDA clearance in order to market your medical device.
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Submit your Pre-market Notification or 510K if required.
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Submit your Pre-market Approval application or PMA if applicable.
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