FDA 510(k) third-party review

A 510(k) is a premarketing submission made to the FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent (SE), to a legally marketed device that is not subject to premarket approval (PMA). 510(k) (premarket notification) to the FDA is required at least 90 days before marketing, unless the device is exempt from 510(k) requirements.

Who has to submit a 510(k)?

Manufacturers must submit a new 510(k) when introducing a device into commercial distribution for the first time, proposing a different intended use for a medical device from that which they already have in commercial distribution, or if they wish to modify a device already on the market in a way that could significantly affect its safety or effectiveness.

What is third-party review?

To improve the efficiency of the 510(k) process, the FDA created the Accredited Persons Program, which authorized third parties to conduct the primary review of 510(k)s for most eligible devices. As an Accredited Person, UL is able to review a manufacturer's 510(k) information and offer a recommendation to the FDA as to whether the device is substantially equivalent to other legally marketed devices (predicate devices) in the United States. The FDA will then determine whether to grant market clearance. UL is accredited to review 510(k)s for all devices eligible under the Accredited Persons Program.

The UL advantage

Since program inception, UL's engineers have reviewed more 510(k)s in the FDA third-party program than any other accredited entity! UL's experience in providing the 510(k) service is one reason why so many global medical device manufacturers have come to UL as their preferred 510(k) reviewer.

• Time -- By law, the FDA must take action on a submission from an Accredited Person within 30 days compared to the 90 days the FDA can take to respond to a direct submission.
• Money -- There are no FDA user fees imposed to Third Parties.
• Expertise -- UL has completed more reviews than any other Accredited Person since program inception.
• Guarantee -- UL draws on our experienced and dedicated staff to provide our service. We are so confident in our staff's experience UL guarantees that your 510(k) submission will be reviewed and submitted to the FDA for SE determination in 2 weeks or your 510(k) is free.
  Two week review is 10 business days and is contingent upon receipt of the full documentation package required for 510(k) review. It does not cover any noncompliant issues that develop as a result of the review. Non-pilot devices only. 2-week notice required prior to submittal.

Additional Resources

• "510(k) Accredited Persons Program" Article Reprint available for download on UL Knowledge Services Thought Leadership pages under "Health Sciences."
• Download UL's FDA 510(k) toolkit, which contains helpful checklists and resources to help you get your 510(k) ready for submission (registration required)
• Download white paper on the Accredited Person's Program by Harvey Rudolph, Ph.D. (registration required)