Dear Alan,

a 510 K exempt device has still to comply the following requirements:
* Establishment Registration and listing (FURLS account). Around 3700 $ per year

* USA free agent sales. 500-900$ per year.

* Manufacturing practiques GMP´s (unless if it is exempt due to the product classification). Similar requirements to the ISO 13485.

4-Adulteration, Misbranding and Banned protection.

Alan Farthing Thanks for the information, Jose. Does this refer to a single stock unit or to all sizes of a product type? is the last item simply specific insurance?

Jose is spot on. One of our devices is exempt, and we still have all the normal rules to follow. Just think of this as a registered medical device without the need to gain approval to sell.

Mark Schnapf Well put Steve. Excellent explanation to the question.

Andrew Kyle I agree. There are subtle difference between a medical device and a medical component. A medical component may be part of a medical device e.g., power supply.

Alan Farthing Thanks for the info guys. To clarify, in this case the product is a simple toothbrush and, as you can imagine, the potential cost benefit depends a lot on the extra costs not required in EU.

James (Jim) Dent, LSSBB, DTMx2 If it's an electrical toothbrush, it could/may be Class II.

Andrew Kyle A toothbrush would most likely be Class I. There should be other toothbrush manufacturers you can locate at FDA.GOV... then find how their devices are classified and what class they are under. Most Class I devices require no 510(k) to market. You will have to be in harmony with the FDA GMP requirements and be periodically inspected to review your processes and complaint files.

Andrew Kyle http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=872.6855 - for manual toothbrush.
electric toothbrush is classified under 872.6865

Both appear to be Class I exempt devices and you should be able to market directly. Don't forget you will need a Design History File available for GMP compliance reviews and this is a suite of documents to substantiate the requirement to validation design. It would be, in my mind, important to have a detailed Risk and Hazard Analysis - for instance what are the brush bristles, have they been substantiated to be "bio-compatible" and have the bristles been subjected to pull tests to verify they are securely affixed. What would happen if someone swallowed the bristles... I don't know would not be a good answer during a GMP visit.
Hope that helps.
Andrew

James (Jim) Dent, LSSBB, DTMx2 @Andrew: thank you for the clarification on electric toothbrushes.

Alan Farthing Thanks Guys.
For info it's manual toothbrushes.