FDA Classification the FDA Is

Given that there is no expectation of substantial equivalence, the following process will need to be undertaken.

The 510(K) that needs to be submitted is the Traditional. A Special is for modifications to products that already have 510(k) approval, so that does not apply in this case. An Abbreviated 510(K) applies when a product is approved for this process by the FDA. There is little explanation on the FDA website of what that means, or what the definitions of the terms it uses are. But with a device that does not have equivalence, there is little likelihood that with new technology this product would be eligible for the abbreviated FDA process.

The different types of documentation that need to be submitted along with the Traditional 510(K) can be found here: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/ucm134572.htm

The decision letter is the final stage of the process, wherein the FDA informs the company of its decision about the device approval.

There is no indication of how long the review process will take, but the company may submit a request for information about the status only after 90 days, and then every 30 days subsequent to that (FDA.gov, 2010).

Works Cited:

FDA.gov. (2009). 510(K) Substantial Equivalence decision making process. FDA.gov. Retrieved April 16, 2012 from http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/ucm134783.htm?utm_source=fdaSearch&utm_medium=website&utm_term=substantial%20equivalence&utm_content=10

FDA.gov. (2009) How to prepare a traditional 510(K). FDA.gov. Retrieved April 16, 2012 from http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/ucm134572.htm

FDA.gov. (2010). Medical devices. FDA.gov. Retrieved April 16, 2012 fromhttp://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/default.htm.