Get Your Low to Moderate Risk Medical Devices to Market Quickly with a 3P510k Review

Assorted Medical Supplies

Speed up the FDA approval process with a third party 510(k) review from SGS.

A 510(k) is the most common way to place a medical device on the US market. Under a traditional 510(k) submission, you must wait 90 days before you can request a status update from the FDA.

If your medical device is low to moderate risk, a third party 510(k) review from SGS will make its journey to market quicker. With a 3P510k review, the FDA must respond to status updates from SGS, the third party, within 30 days. This will save you a significant amount of time. A 3P510k reviews allows the FDA to maintain oversight of the review process but focus its resources on higher risk devices.

The 3P510k Process

One

You submit your file to SGS. We review and make recommendations, then send to the FDA.

Two

The FDA makes its final decision and informs SGS.

Three

We let you know what the FDA has decided.

Is your device eligible for a 3P510k review?

Risk Profiling

Associated Risk

Your device should be low risk. Multifaceted or interdisciplinary expertise is not needed to perform the conformity assessment.

Tailored Solutions

Complexity

Your device should be well understood. Information needed to assess the device is publicly available.

NDVI

Post-marketing Surveillance

Your device should not have post-market safety signals. Thus, it cannot be an entirely new medical device.

Our Expertise and Resources

  • Our team of in-house reviewers has received training from SGS and the FDA
  • SGS can consult with the FDA during the 35P10k review process
  • Both SGS and the FDA have committed resources to ensuring that FDA standards are built into the program
Two Scientists

Webinar

Understanding the FDA 3P510K Guidance for Third Party Review

Register to listen the webinar

Stethoscope

Webinar

Get your medical device to the USA market quickly and efficiently

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Why SGS?

SGS is the world's leading inspection, verification, testing, and certification company. SGS is recognized as the global benchmark for quality and integrity. With more than 89,000 employees, SGS operates a network of over 2,600 offices and laboratories around the world.

Contact us to learn more.

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