Julie Omohundro If the device is 510(k) exempt, there is nothing to file, but you have to register the appropriate establishment(s) and list the device:

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/RegistrationandListing/

Registration & listing are done electronically through FDA's electronic gateway. If you don't have an IT department, I recommend finding a US agent that can handle registration & listing for you. (You will need a US agent regardless.)

Anne T. Thank you very much for your kind help and useful information, Julie!

Julie Omohundro You're very welcome!

Andrew Kyle If the device is exempt you must still maintain a DHF and it must document the predicated Class 1 devices You may have the DHF reviewed during routine GMP visits and it must maintain the same integrity as a non- 510(k) product. The 510(k) notifies the FDA that you plan to market a product SE to others already in the market
You have to register with the FDA yearly and list its trade name.

There are many regulations and other factors (e.g., V&V, ISO 13485, etc) you must address. Standards such as Iec60601 safety and emc requirements if the device has a AC power supply or battery voltage exceeding 24v. If the device includes software, it may not be exempt. You need an independent evaluation of the product and its predicated device

Julie is correct in saying that you only need to list your Class I device (as well as register your company) with the US-FDA. Andrew is correct if your device is NOT exempt from the Quality System (QS) regulation (CFR 820). If it is, then you don't have to keep DHF, etc. Check the classification of your device on the FDA website (look for the 21 CFR ???.????) and it will tell you if it is exempt from premarket notification and/or QS. Regardless, you have to comply with other regulations such as labeling, customer complaints and adverse event reporting. Good luck!

Julie Omohundro Andrew, you are correct that there will be a number of regulations that apply to a Class I device even if it is 510(k) exempt. Those requirements will vary, depending on the specific device. Some Class I devices are exempt from GMPs, only a handful must comply with design controls, etc.

Anne T. Thank you a lot for this detailed information, Andrew!

AnneThe FDA requirements for 510k exempt devices remain very complex. Though you can register your device with the FDA just by going onto the website and registering, you will find you need to go deeply into the sourcing of your device, and that you will need to keep quality assurance files. The requirements are hard to intuit. You might want to get in touch with a contract medical device manufacturer with experience in this field. I found Paul Serio of Accumedix, in Grayslake IL. His company took my device into a safe area where it can be properly vetted. Contact him at paul.serio@accumedix.com

The FDA tutorials and the written explanation in the FDA internet site are quite clear. I did it for the first time this year with no difficulties. Just follow instructions. Remember to write down all the Identification codes. They will be very usefull for the shipping documents.

Anne T. Thank you a lot for your generosity to share your professional knowledge wit me, Binseng Wang, Douglas G. Mann, and Bruno Sommacal!

It looks like you got your questions answered, Anne, but if you have more questions feel free to message me!

Anne T. Thank you a lot, Samuel!

This indeed sounds more like an admInistrative issue than a regulatory filing w or w/o FDA 21 CFR Part 820 compliance for further inspection.