Emergo 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.
Who must submit a FDA 510(k) Premarket Notification?
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.
Step 1: Pre 510(k) Gap Analysis and Preparation Consulting
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.
- Our 510(k) consultants evaluate the classification of your medical device or IVD and determine the proper FDA product code and regulation number.
- We determine which similar (predicate) devices already have FDA 510(k) clearance and whether they are suitable for use in your 510(k) submission.
- We review testing requirements, applicable FDA guidance documents and required standards.
- We provide a detailed product-specific list of documents needed for review by our 510(k) consulting team.
- We provide a detailed list of documents, reports, diagrams or clinical data needed before 510(k) preparation can begin.
- With input from you, we prepare a technical comparison of your medical device to other predicate devices with FDA 510(k) clearance.
- Emergo carefully evaluates this documentation and prepares a detailed gap analysis report showing what information you have and which data will be required for a successful 510(k) submission.
Step 2: FDA 510(k) Compilation and Submission
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:
- Prepare all 21 sections of the FDA 510(k) application.
- Coordinate your payment of FDA 510(k) submission fees on your behalf.
- Submit the 510(k) to the FDA and be available as your FDA consultant to answer follow-up questions from the FDA reviewer.
- Upon clearance of your device, we will guide you through the Establishment Registration process with the FDA.