510(k) Writing and Prep
510(k) Basics
If you have a medical device that you would like to market in the U.S. for human use you must first get clearance (or approval) from the FDA. Unless of course, the device is exempt from 510(k) requirements. A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is safe and effective AND substantially equivalent, to a legally marketed device.
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Trust in us to write it for you. We have experience writing 510(k)s that are complete, concise and successful. Your 510(k) should be written in a manner that is easy to understand while also providing all pertinent information. We know exactly what FDA is looking for.
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We can also assist with editing your already-written 510(k). We will review your document and provide suggestions along with commentary to ensure that your 510(k) is in the best shape before it goes in front of FDA. Already an impeccable writer and don’t need help, but need a template? We can help with that too!