Let UL's Team of Experienced Engineers Save you time on your next 510(k) Submittal
Since program inception, UL has reviewed more 510(k)s in the FDA third Party program than any other Accredited Person! 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.
What is a FDA 510(k)?
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?
In order 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.
"UL's prompt and insightful FDA 510(k) reviews have been extremely helpful to Philips/ADAC, enabling us to deliver products to the U.S. in a timely manner. UL's team truly adds value to our organization by consistently providing us with their regulatory submission review expertise, as well as efficient, reliable service."
- David Kolesar, regulatory affairs director, ADAC - A Philips Medical Systems Company
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Benefits of UL's 510(k) Third-Party Review Service
- 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 Weeks¹ or your 510(k) is free.
For additional information on UL's Medical Business Unit and Global Regulatory end-to-end Solutions, please contact us at: +1-877-854-3577 ext. 49462 or email: Medical@us.ul.com
¹2 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 non compliant issues that develop as a result of the review. Non-pilot devices only. 2-week notice required prior to submittal.
