There are three legal ways to get medical devices on to the US market. 510ks PMA's Exempt Devices In order to know which is needed for any given device, you first have to determine how the device is classified by the FDA. Sometimes this is easy and sometimes the FDA doesn't even know how they are going to classify a new device. Let's start with the quickest and easiest route, Exempt Devices. These are low risk devices, usually Class I. They are exempted from premarket (510k of PMA) requirements and sometimes are exempt from GMP requirements. What you need to do is file the Establishment Registration, get a US Agent and file your device listing. BUT, you cannot extend intended uses beyond what the regulation allows or you loose the exempt status and will need a 510k or PMA. The next easiest way is 510ks. Some Class I devices require 510ks, most Class II devices require 510ks, and a few Class III devices require 510ks. This whole concept is based upon "substantial equivalence" and is unique to the US medical device regulations. So, the objective is to show that your device is substantially equivalent to some other device(s) already on the US market. What this means is that your device is safe and as effective as the predicate device(s). This route involves assembling a file, paying $4,158 user fee, submitting it to the FDA or an acceptable third party for review and waiting for their go ahead before selling on the US market. FDA gets 3 months to review 510ks. The most difficult path is the PMA (PreMarket Approval). Most Class III devices require PMAs as these are the highest risk classification in the US. These are a big deal and take years since you have to demonstrate both the safety and efficacy of your device. The FDA user fee for reviewing PMAs is $281,600. QNET has experienced medical device professionals to help you through the process Contact QNET