When it comes to a 510(k) submission, making sure that the process runs as smoothly as possible can be quite challenging. Testing medical devices takes a lot of time and expertise to determine a final decision. After all, it is up to the FDA to ensure that all products passing the 510(k) are suitable for human use in terms of safety and effectiveness etc. Testing medical devices should be completed in advance to better understand the product and to help determine its performance capabilities as well as its safety levels etc. So, how can you ensure that your Premarket Application passes the finish line without any problems?
It is so important to carry out adequate testing protocols before sending your device off to the FDA, only to be criticised right, left and centre. You must carry out a range of tests to determine various aspects of the device such as strength, fatigue, power and quality etc. This is also incredibly important if your device has undergone any changes. Feasibility testing is important because your device may fail the 510(k) submission testing period if it does not live up to the expected and necessary standards.
Submitting your final 510(k) to an Accredited Persons will quicken the time it takes for the FDA to complete your review. Simply submit your 510(k) to a third party review company and they will carry out the initial reviewing process. Once this stage is complete, your submission is forwarded to the FDA, who then have a deadline of 30 days to complete the review. Companies to help with FDA 510k include FDA Third Party Review, who are able to save you both time and money.
Understand your Predicate
A predicate device is the “comparative device” that you need to compare with your existing product. This is required in order to prove its substantial equivalency, which requires that your device showcase similar properties to a device that has already been approved by the FDA and that showcases similar aspects such as material, size, effectiveness, safety and other essential and relevant product factors. You must ensure that these devices are acquired before testing.
Protocols include information such as test methodology, indication for use, deviations and relevant drawings etc. By ensuring your protocols include the right information and details about your device, you avoid experiencing any delays caused by inaccurate or missing information. This is an important part of the 510(k) submission process. Accutek Testing advises that you make sure that you begin the protocol stage of your submission as early as possible because it tends to be quite time consuming.