If you think that your medical device is similar to others already in the marketplace, Donawa Lifescience Consulting can help. After confirming that the product is either a Class II medical device or a Class I device that is not exempt from the premarket notification requirements, we can assist you in the filing of a 510(k) submission with the FDA.
A 510(k) is a premarket notification made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is ‘substantially equivalent’ (SE), to a legally marketed device. We can help you to collect and prepare the supporting documentation which compares your device to one or more similar legally marketed devices and then make and support your substantial equivalency claims.
Even if FDA does not require the results of a clinical study (or performance evaluation study) in your 510(k) submission, comparison studies with the selected predicate device(s) are generaly required. Results of studies from at least three sites, including one in the US, is often necessary, including compliance with all relevant clinical aspects, such as site selction, IRB approval, informaed consent, etc. We can provide assistance with regard to clinical and statistical issues for these method comparison studies.
GEMAR can also assist you in the determination of whether or not a new 510(k) is needed for a modification to an existing Class II device that is already on the market, and which type of 510(k) submission is best suited to your device: traditional, special or abbreviated.
If there is no legally marketed similar device available on the US market, it may be possible to utilise the 'de novo' 510(k) route, as long as your device is 'low' or 'medium' risk.