Owners or operators of places of business (also called establishments or facilities) that are involved in the production and distribution of medical devices intended for use in the United States (U.S.) are required to register annually with the FDA. This process is known as establishment registration.
One of the first steps towards selling a Class II medical device or IVD in the United States is to file a Premarket Notification with the FDA, also known as an FDA 510(k) submission.
HOW REVEREIT CAN HELP WITH 510(K) SUBMISSIONS
we have successfully prepared and submitted FDA 510(k) submissions for medical device and IVD companies from around the world seeking to sell in the United States. To ensure a successful 510(k) submission, we take a two-step approach to obtaining 510(k) clearance from the FDA. Over the years we have found that this approach is cost-effective for our clients, and it dramatically reduces the probability of a failed or abandoned FDA 510(k) submission.
STEP 1: PRE 510(K) GAP ANALYSIS AND PREPARATION
- Based on the proposed intended use and design of your device, we evaluate similar devices (Predicate Device) that already have FDA 510(k) clearance to determine whether any are suitable for use in your 510(k) submission.
- The chosen predicates help us determine the proper FDA product code and regulation number, which may point to device-specific guidance documents or required standards to use.
- We provide a detailed product-specific list of documents and information needed for review by our U.S. regulatory consultants.
- After evaluating this documentation, we prepare a detailed gap analysis report showing the information you have and what additional data will be required for a complete 510(k) submission.
STEP 2: FDA 510(K) COMPILATION AND SUBMISSION
Once you receive comprehensive gap analysis identifying 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 a technical comparison of your medical device to the predicate device(s). Prepare all 21 sections of the FDA 510(k) application.
- Submit the 510(k) to the FDA and answer follow-up questions from the FDA
- Coordinate your payment of FDA 510(k) submission fees on your behalf.
- Immediately communicate with you regarding all information received from the FDA following the 510(k) submission.