Approvals for medical devices in the USA

Approvals for medical devices in the United States

In the US market, many medical devices are cleared for sale by a 510(k) Pre-market Approval. TÜV Rheinland of North America is accredited by the US Food and Drug Administration (FDA)  to carry out 510(k) reviews. We make sure of your market access with our know-hows and wide network of 340 offices in more than 60 countries.

The Food and Drug Administration (FDA) will require a 510(k) submission for most Class II devices for you to sell medical devices in the US market. With this submission, the FDA can check whether your product is equivalent to a product approved in the United States and fulfils US safety and effectiveness requirements.

• With you, we check whether your product is suitable for an independent appraisal. This applies to 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 requests the review, we will check the documents that you have submitted. 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.
• With the 510(k) documentation, we will send our assessment along with your documents to the FDA.
• If a target date is agreed, we will review your documents in less than four weeks.
• The FDA will then notify us within 30 days at the latest of its decision on whether the 510(k) documents can be accepted or not.

Notification is usually received within 14 days.
We will give you a notice as soon as we receive the result.