In the FDA-regulated medical device world, there are 3 classifications for medical devices: Class I, Class II and Class III. The FDA (http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/ClassifyYourDevice/default.htm) provides a rather in-depth overview of how to classify a medical device and the requirements behind each product's classification. What may not be evident, or often discussed in common conversation, is that many Class I and some Class II medical devices are 510(k) exempt.

What does 510(k) exempt mean? When a 510(k) submission is required it means that the FDA is requesting notification, along with evidence that the medical device intended to be marketed is safe and effective, prior to a company commercializing its product. In some instances though, the FDA has placed specific medical devices into an "exempt" status. Now, this is not to imply that the FDA does not have requirements for Class I/II 510(k)-exempt devices. The FDA in fact specifies that companies manufacturing 510(k)-exempt devices still follow certain regulations such as: Registration and Listing, Corrections and Removals, Labeling, and GMP's (good manufacturing practices)) (http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/ClassifyYourDevice/ucm051549.htm). Of course, you could get lucky and manufacture 510(k)- and GMP-exempt devices, but that's a separate blog post.

Though, it still isn't enough to simply check with the classification database and, if 510(k)-exempt, market your product without care. There are clauses in the regulation that void the 510(k) exemption, most notably if utilizing a new technology in a 510(k)-exempt device, or having a different intended use than what is commonly associated with the 510(k)-exempt device. A great example of the first scenario is how the FDA has looked at some recent design changes in the orthotics industry. Many companies have added electronics or robotics to the orthotics to enhance their usefulness. That shift is viewed as a "new technology" change and would require a 510(k).

When beginning your regulatory strategy, or starting your company, the best "first step" would be to visit the following website: (http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/315.cfm), a full listing on the FDA website of 510(k) exempt devices. You could be one of the "lucky few" to see that your path to marketing your device is a bit easier.

-MJB

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