SGS has received U.S. Food and Drug Administration (FDA) approval to participate and provide services for third party 510(k) premarket submissions for medical devices.

What is a 510(k)?

A 510(k) “is a premarket submission made to the FDA to demonstrate that the device to be marketed is substantially equivalent, to a legally marketed device.”

Benefits of a Third-party 510(k) Review

The program is intended to help yield more rapid 510(k) decisions. To prepare 510(k) paperwork is complex and time consuming. By working alongside a third-party, such as SGS, we can help to shorten the process to get your 510(k) medical device cleared through the premarket notification.

As a recognized third party review organization, SGS is allowed to review medical devices as listed on the FDA website.

FDA SGS Process

Fig. 1 510(k) Third Party Review Program1

 

Jonathan Hall, Global Head of Certification, SGS said: “This approval from the FDA once again reiterates SGS’s market-leading position in the testing, inspection and certification industry. By being able to offer this additional service to the medical device sector, we are able to better enable our clients to bring safer products to the market faster. Our team of experts are now fully trained and equipped to support clients in 510(k) premarket submissions.”

Medical Device Solutions

SGS helps manufacturers to bring medical devices to market safely and efficiently, from large established companies to new start-ups. SGS provides complete solutions to support the medical devices industry meet customers and global regulatory requirements from training, product testing, quality system certification (i.e. ISO 13485, MDSAP) and product certifications (CE Marking, 3P510K), services such as SGS Transparency-One and Customized Assessment Tracking System (CATS), leading in technology to help companies manage their supply chains.

For inquiries, please contact:

Joseph (Greg) Jones
Technical Director - Medical Devices
SGS North America
t: +1 201 296 5353

Reference

1 510(k) Third Party Review Program

About SGS

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