United States
US FDA 510(k) Consulting for Medical Devices and IVDs
How Medapproval LLC can help with 510(k) submissions:
As an FDA medical device consulting firm, we have successfully prepared and submitted FDA 510(k) submissions for medical device 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 Consulting
Based on the proposed intended use and design of your device, we evaluate similar devices that already have FDA 510(k) clearance to determine whether any are suitable for use in your 510(k) submission. These are referred to as predicate devices.
- 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
We provide a comprehensive gap analysis identifying exactly what information will be needed for your 510(k) submission, Medapproval 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.
- Contact us to learn more about what happens after 510(k) regulatory clearance.
We want you to be successful in introducing your device to the US market and we find this two-step approach to be the most cost effective and efficient means of achieving FDA approval.
Please contact us for more information on our FDA 510(k) consulting services.
US FDA Agent Representation For Medical Device and IVD Companies
United States Food and Drug Administration (FDA) requires all medical device and IVD companies without a location in the United States to appoint a registered US FDA Agent.
The US FDA Agent must be a resident of the United States or maintain a place of business in the US. Your US Agent will serve as a liaison between your company and the FDA.
Appoint Medapproval as your US FDA Agent
Here’s why you should choose us:
- We will communicate with the FDA on your behalf and respond to any questions concerning your medical devices.
- We focus on regulatory compliance and will ensure that all of your regulatory responsibilities are handled professionally, confidentially and promptly.
- As an independent "third party" representative, we will always look after your interests first and foremost. Manufacturers who appoint a distributor to act as their FDA US Agent can experience challenges in this regard.
Please contact us for more information on US FDA Agent representation.
Contact us
11555 Medlock Bridge Rd, Ste. 100
Johns Creek, Georgia 30097
qara@Medapprovalllc.com
1 (864) 735-2466