When completing your 510(k) clearance submission for FDA approval, you will be required to demonstrate that your device is both safe and effective. According to the rules and regulations of submitting a 510(k), the FDA states that you can prove the effectiveness and safety of your product by proving its substantial equivalence to an existing legally marketed device, otherwise known as a predicate device.
What is a Predicate Device?
The predicate device must have been legally marketed before 28th May 1976 and obviously pre-approved by the FDA. According to Device Watch, when submitting your 510(k), you must accurately compare and associate the similarities between your device and that of your predicated device. The devices do not have to be completely identical to each other, but rather, they must share similar aspects such as intended use, energy used, deign, performance, standards, labelling, effectiveness, safety and other relevant characteristics.
How to Find a Predicate Device
Finding a suitable predicate device is usually the stage of the 510(k) submission that most applicants dread. However, it is actually quite simple to find one since the FDA owns a huge database that contains a list of previously cleared 510(k) devices and this list is constantly being updated. To find which of these devices is suitable, you must take your product code and search for it in the Product Code Classification Database. This will then bring you to your specific classification of your device and you will be given a list of similar device types previously cleared by the FDA 510(K). You can also search for manufactures names, devices and other search terms to find a suitable predicate device to your own.
510(k) Clearance Guidance
People are easily intimidated by 510(k) clearance. It seems like a mountain of a task and one better left to the professionals. A huge drawback is the sheer amount of time it takes to have your submission cleared by the FDA. This process can take months to complete. To avoid the long queue of stacked 510(k) submissions, it’s probably a better idea to choose an Accredited Persons to help instead. These are FDA approved companies to help with FDA 510k Clearance submissions. Third Party Review companies such as fdathirdpartyreview are able to review your submission and forward their findings to the FDA. This works out to be a lot less time consuming because the FDA are obligated to respond with their final decision within 30 days.