Approvals for medical devices in the USA

In the US market, many medical devices are cleared for sale by a 510(k) Pre-market Approval. TUV Rheinland of North America Inc. is accredited by the US Food and Drug Administration (FDA)  to carry out 510(k) reviews. Make sure of swift market access by making use of our know-how and our local presence!

For you to be able to sell your medical device on the US market, the Food and Drug Administration (FDA) will need a 510(k) submission for most Class II devices. With this submission the FDA can check whether your product is substantially equivalent to a product that is already approved in the United States and fulfils US safety and effectiveness requirements.

• Together with you we check whether your product is suitable for an independent appraisal. This is the case for all products on the FDA’s list of devices for third party review. Please ensure that you also check out the Web page www.fda.gov/cdrh/thirdparty/.
• If your product is listed, simply fill out the Quotation Questionnaire overleaf.
• We will review your application for compliance with FDA requirements. Then we will quote you for the job.
• If you then instruct us to perform the review we will check the documents that you submit. Throughout the procedure we will stay in close contact with you. If discrepancies arise, we will clarify them with you directly before we submit the documentation to the FDA. This ensures that the entire procedure can go ahead without a break.
• We will then go ahead with the 510(k) documentation and send in our assessment along with your documents to the FDA.
• If a target date is agreed, we require less than four weeks for our review.
• The FDA will then notify us within 30 days at the latest of its decision on whether the 510(k) documents can be accepted.

Experience has shown that notification is usually received within 14 days. We will notify you as soon as we receive the result.

Do you have any further queries? Contact us, we look forward to hearing from you!