510(k)

A company that wishes to sell a medical device in the United States, in most cases, must submit a Premarket Notification [510(k)] to the FDA. This submission is referred to in Section 510(k) of 21 CFR (Code of Federal Regulations) Part 801.

A 510(k) is a submission to the FDA which illustrates for the FDA how a product is similar to a product that is already legally marketed. When the FDA agrees that the new product is substantially equivalent, the device can then be marketed legally.

Regulatory Specialists, Inc. has years of experience which is combined with a speedy and successful track record of submitting 510(k)'s to the FDA. Assistance with 510(k) submissions can take several forms. Some clients prefer that we conduct the entire submission. Others request guidance while they perform a majority of the submission procedures themselves. Regulatory Specialists, Inc. is flexible and can help each type of client according to their specific needs.

PMA

A Pre-Market Approval (PMA) is necessary from the FDA for medical devices that do not have a legally marketed product to which it can claim substantial equivalence. It is also needed for a new type of product. A PMA may be necessary for medical devices for which there is not sufficient existing information regarding the safety and effectiveness. Additional studies, such as human clinical testing, are often required. Regulatory Specialists, Inc. has vast experience helping clients satisfy requirements to obtain PMAs.