FDA 510k Reviews

As a Federal Drug Administration (FDA) 510k 3rd Party Reviewer, Intertek can get your medical device reviewed and cleared significantly faster.

Intertek is an FDA accredited body, allowing us to get your medical device reviewed and cleared faster than a direct submission to the FDA. Our expert reviewers have extensive experience with a vast range of medical device types, providing a higher probability of a successful 510k submission on the first pass.

By increasing the probability of your first-time submission success and expediting the FDA 510(k) process, we help deliver your medical product to customers faster, thus increasing the profitability of your organization.

Send a request to partner with us today.

We offer a 10 day Real Time service for FDA 510(k) Reviews: 

• Real Time Review – 10 business day turnaround. Guaranteed. Your 510(k) submission will be reviewed and submitted to the FDA in 10 days or it's FREE.* The reviewer is in contact with the sponsor to communicate deficiencies as they are found. Sponsor is able to respond to the deficiencies and Intertek's reviewers will review immediately.

 

Years of Experience Working With FDA
Our expert 510(k) reviewers apply product knowledge and industry experience to complete your product review quickly - with a higher probability of FDA approval on the first pass. The FDA is required to respond to Intertek's submission within 30 days, compared to the 90 days the FDA can take to respond to a direct submission. Intertek will help you get your product to market faster, as much as 50 days, or nearly two months, faster!

Medical Device Products We Test 

About the FDA 510(k) Review Program
Section 510(k) of the Food, Drug, and Cosmetic Act requires medical device manufacturers to submit a premarket notification for applicable devices if they intend to introduce a device into commercial distribution for the first time or reintroduce a significantly changed or modified device. This process allows the FDA to determine whether the device is equivalent to a device already on the market to ensure the safety and effectiveness of all medical devices on the market.

The FDA 510(k) Third Party Review Program allows outside FDA-accredited conformity assessment organizations, such as Intertek, to conduct 510(k) reviews. The purpose of the program is to maintain high-quality 510(k) reviews and shorten review times by using outside expertise and resources. The overall efficiency of the third-party review program enables you to deliver products to market faster.

* The 10-Day Real Time Review is 10 business days from the start of the review and is contingent upon receipt of the full submission package required for the 510(k) review. It does not cover any deficiencies remaining open after the 8th business day. Pilot devices excluded.  

Contact us to see how Intertek can help your organization with FDA 510k Reviews.