There are 3 classes: Class I, II, and III. They are classified based on risk, with Class I being the lowest and Class III being the greatest.
You will find out what pre-marketing submission is required by FDA based on classification of your device. General Controls are assigned as Class I either with or without exemptions. General Controls and Special Controls are assigned as Class II either with or without exemptions. General Controls and Pre-market Approval are assigned as Class III.
Every device has a regulation number. You will need this number to determine the classification of your device. Go to database at website http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm.
Look for a part of the name of your medical device or if you know the medical specialty, enter it where it says Device Panel.;
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Go to CFR search page at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm.
Read the information on regulation such as general provision, packaging and labeling and other pertinent information on CFR.



If your device falls under Class I or II without exemptions, you will be required a Pre-market Notification or 510K for marketing.
If your device falls under Class III, you will be required a Pre-market Approval or PMA unless it is a pre-amendments device (which means on the market before the medical device amendments passage in 1976 or an equivalent device). In that case, you will then be required a 510K.



For a list of 510k Forms, go to http://www.fda.gov/MedicalDevices/ and enter keyword "Pre-market Notification Form" on search tool. Select the link to 510k Review Fees and you will have the option to select from the menu all the necessary information for 510k submission process.



Go to http://www.fda.gov/MedicalDevices/ and enter keyword "Pre-market Approval" on search tool. Select the link to Pre-market Approval (PMA) and you will be prompted to the page where you can submit your application and obtain all the necessary information for the PMA process.
Determine the classification of your medical device.
Search regulation for your device after you find out the device panel on CFR or Code of Federal Regulation Title 21.
Find out if you can get FDA clearance in order to market your medical device.
Submit your Pre-market Notification or 510K if required.
Submit your Pre-market Approval application or PMA if applicable.
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