FDA approval process for medical devices

FDA

Classification

The FDA is deliberately unclear on its website as to how devices are classified. This type of regulatory incompetence is one of the hurdles that can delay getting the product to market. We believe that the non-invasive glucose monitoring system will be a Class II product, based on its level of technology, but the fact that it has limited health risk to the patient as a non-invasive device. A Class I device is not subject to any restrictions on premarket approval, but these devices are generally those with very little technology, for example a tongue depressor. A Class III device, by contrast, would be one that is invasive and therefore subject to the highest level of control.

Substantial Equivalence

Establishing substantial equivalence reduces the regulatory process, as it is assumed that if the equivalent products were approved, then our product would be approved. In order to established substantial equivalence, a product would need to have the same purpose as an existing device and have the same technology. In this case, there are no similar products currently on the market. The existing glucose monitors are all invasive, requiring the price of the skin, whereas ours does not. Because of this difference in technology, it is unlikely that the FDA would find substantial equivalence and therefore our product would need to go through the full approval procedure for Class II medical devices (FDA.gov, 2009).

Steps in the Process

Only Class I products do not require premarket approval. The first step in the premarket approval process is the 510(K) form. This form is intended to demonstrate to the FDA that the product is at least as safe, if not safer than, an existing product that fulfills the same purpose (FDA, 2010). 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).