3P510k Review

Save resources and money, and shorten the time to market of your medical device with a 3P510k review from SGS.

A 510(k) is the most common way to place a medical device on the US market. A 510(k) is a premarket submission to the US Food and Drug Administration (FDA), claiming a device is safe, effective and ready to be marketed. The FDA reviews it, and clearance is granted or denied.

A 510(k) third-party review, also known as a 3P510k review, provides medical device manufacturers with an alternate process. It allows manufacturers to send submissions to accredited 3P510k review organizations, so they can evaluate certain medical devices for faster decisions.

Under a traditional 510(k) submission, the applicant may only request information from the FDA on the status of their 510(k) review 90 days after its initial submission. On the other hand, a third party, such as SGS, requires the FDA to respond to third-party reviewed files within 30 days. This enables your medical device to get to market faster.

Other benefits include:

• Save time within your organization
• Conserve resources
• Access to an industry expert’s knowledge
• Cost savings

Eligibility checklist

Associated risk

The product should be a low-risk medical device, providing that multifaceted or interdisciplinary expertise is not required to perform the conformity assessment.

Complexity

The device should be well understood, providing that the information the review organization needs to assess the device is publicly available.

Post-marketing surveillance

The device should not have post-market safety signals (thus, the 3P510k program cannot be applied).

How can SGS help?

We provide 3P510k services for low- and moderate-risk medical devices. This allows the FDA to focus its resources on higher-risk devices, while maintaining oversight of lower-risk devices eligible for third-party review.

Preparation for 510(k) is complex and time-consuming. As a recognized third-party review organization, we can help shorten the process of getting your 510(k) medical device through the premarket notification. We review medical devices as listed on the FDA website.

A dedicated team

We have built a team of ex-FDA reviewers, providing additional review training to them in collaboration with the FDA. We can consult with the FDA during a 3P510k review process. Both parties have committed resources to ensure that FDA standards are built into the program.

The fast lane to market

A medical device manufacturer can send their submission information to us, and our experts will review everything and submit the required documents to the FDA.

Our expertise will expedite the process, limit the need for re-reviews and allow you to focus on other aspects of your business. Once the FDA makes its final decision, we will let you know if your device has been approved.

A one-stop-shop for all your medical device needs

In addition to 3P510k reviews, we offer a range of solutions to act as the one-stop-shop for all your medical device needs.

Our certification and training services include ISO 13485 (medical devices quality management systems), Medical Device Single Audit Program (MDSAP), management systems and information security, such as ISO/IEC 27001 (information security, cybersecurity and privacy protection).