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US FDA 510(k) Consulting for Medical Devices and IVDs

US 510k Submissions

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.

Technically, the FDA does not "approve" medical devices or IVDs for sale under the 510(k) process; the agency gives "clearance" for them to be sold in the U.S. We use the term "FDA approval" for simplicity.

See our free whitepaper: Overview of the US FDA 510(k) medical device regulatory process.

Who must submit an FDA 510(k) Premarket Notification?

In general, manufacturers wishing to introduce Class II medical devices (and a small number of Class I and III 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.

See a list of devices EXEMPT from the FDA 510(k) process.

How Emergo can help with 510(k) submissions

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 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

Once you receive comprehensive gap analysis identifying exactly what information will be needed for your 510(k) submission, Emergo 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.

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.

 

Ask us for detailed information about USA FDA 510(k) consulting services.

Learn about the process, costs and timelines.

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Frequently Asked Questions

Will I receive a registration certificate after 510(k) Clearance?
No. You will not receive a registration certificate after 510(k) clearance but the FDA will issue a 510(k) clearance letter and post it on their website. The website posting is your official proof of registration.

How long is my 510(k) valid?
The 510(k) regulatory clearance is valid until changes have occurred to the product, intended use or indications for use. Changes need to be assessed to determine if the changes warrant a submission to the FDA.

If there is a predicate, do I have to do the same testing?
In general, you are required to do performance testing on your device along with any testing that the known predicate did. The test results are to show that your product is substantially equivalent to the predicate.

Can a 510(k) be transferred? Who owns it?
The person who submits the 510(k) is considered the owner of the FDA Clearance and remains so. The purchaser of a 510(k) will list the device as part of their updated establishment registration, and that is considered sufficient to notify the FDA of a new owner. If the manufacturing site changes the company must validate the processes at the new site under the QMS, and the new facility must be registered with the FDA.

What is considered a device family – what products can be in a single submission?
Devices that share the same FDA classification regulation/product code can often be “bundled” into a single submission.

Is home country approval required?
Home country approval is not required to receive FDA clearance.