What is "concurrence" in FDA submissions?

"Concurrence" in the context of FDA submissions refers specifically to the FDA's agreement that a device meets the regulatory requirements necessary for marketing. This concept is crucial in processes such as the 510(k) submissions where the manufacturer must demonstrate that their device is substantially equivalent to a legally marketed device. The concurrence signifies that the FDA has reviewed the submission and agrees with the provided evidence, which includes safety and effectiveness data, thereby allowing the device to be marketed.

This approval process ensures that devices do not hit the market without meeting stringent safety and efficacy standards. It is an essential step for manufacturers looking to gain market access for their products and reflects the regulatory oversight that is fundamental to devices being introduced to patients and healthcare professionals.

The other choices do not encapsulate the specific regulatory meaning of "concurrence" as defined by the FDA. For instance, consumer approval does not reflect regulatory compliance, the manufacturer's consent to FDA review is more about submission logistics rather than concurrence, and mandatory approval for clinical studies pertains to a different regulatory stage before a device can even be considered for marketing.