UL’S FDA EXPERIENCE CAN HELP YOU MEET FDA EXPECTATIONS
There is opportunity for medical device companies to advance healthcare by bringing innovative products to global markets. The U.S. FDA has a unique regulatory system and those new to the medical industry or new to the U.S. market can save precious time by enlisting UL’s help with all aspects of FDA Submissions and Inspections, or discrete parts.
UL has staff outside of the U.S. who can work with you and your team in your local language and time zone and coordinate as needed with our team located in the U.S.
Our previous customers have found value in these services and we are happy to work with you and your unique technology to design solutions to meet your needs.
Our team can provide your in-house team with information on FDA submission requirements, including navigation of the FDA’s website, location of useful guidance documents and necessary forms, submission format and what to expect.
The gap assessment is a review of what you need to have tested and more. Our team can review your current documentation and identify areas where data or test reports are missing so you can have more confidence in your complete FDA submission package.
We can take inventory of your product information and test reports and then outline and prepare the necessary documentation to complete your submission.
UL experts can provide guidance during regulatory submission.
The Mock review is looking at the whole 510(k) submission to see if it meets the FDA requirements. As a former 3rd Party reviewer, UL is familiar with FDA and 3rd Party reviewer expectations for 510(k) submissions. UL’s ex-review staff can review your 510(k) submission package and provide detailed feedback and recommendations regarding the entire submission.
As an independent advisory partner, we can help with reviewing and advising on responses to requests for additional information, as well as set up teleconferences or meetings with the FDA reviewer to address questions. We can also recommend and set up pre-submission requests or meetings in order to identify potential problems or areas of concern.
We offer support after the FDA has completed their inspection, including MDR filing and justification, Form 483 and warning letter response and remediation and consent decree remediation and independent third party validation
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