Emergo Group acts as FDA regulatory consultant for medical device and IVD companies from around the world seeking Food and Drug Administration (FDA) approval to sell their products in the United States. One of the first steps for medical device companies that manufacture Class II medical devices and IVDs (and a small number of Class I devices) is to file a Premarket Notification, also known as a FDA 510(k) submission, with the Food and Drug Administration.
Technically, the FDA does not "approve" medical devices or IVDs for sale under the FDA 510(k) premarket notification process; the agency gives "clearance" for them to be sold. As FDA 510(k) consultants, we use the term "FDA approval" for simplicity. To be cleared for sale by the FDA, the first step is to identify a Predicate Device(s), which is a medical device already cleared by the FDA and is similar to the one for which FDA approval is being sought.
As an FDA medical device and IVD consulting firm, we have successfully prepared and submitted FDA 510(k) submissions for medical device and IVD companies worldwide.
In general, manufacturers introducing Class II medical devices or IVDs to the US must submit a 510(k) to the FDA. A 510(k) is also required for manufacturers changing the intended use of their medical device, or changing the technology of a cleared device in such a way that it may significantly affect the device’s safety or effectiveness.
To ensure a successful 510(k) submission, Emergo Group takes a two-step approach as your FDA consultant to obtaining 510(k) clearance from the FDA. We have found that this approach is most cost effective for our clients, and it dramatically increases the probability of a successful FDA 510(k) submission. The steps of our FDA 510(k) consulting approach are outlined below.
Once the gap analysis has been completed, you will then have a comprehensive document that identifies exactly what information will be needed for your 510(k) submission. We can then help you close these "gaps" and prepare your final 510(k) submission. We will: