To simplify and streamline the premarket review process, applicants may utilize FDA recognized standards in premarket submissions. Consensus standards are often very useful when an FDA-recognized consensus standard exists that serves as a complete performance standard for a specific medical device. In these cases, the standard may include specific acceptance criteria that describe the relevant performance characteristics of that specific medical device. Conformity to the recognized standard should, in these cases, minimize the amount of data and documentation needed in the 510(k) submission to demonstrate substantial equivalence. However, such comprehensive consensus standards are rare.

If applied appropriately, conformance to other more general vertical standards (i.e., device specific standards that may not encompass all aspects of device performance) can also serve as a means to streamline the premarket review process. Conformance and declarations of conformance to any recognized consensus standard that clearly spells out acceptance criteria is a very effective use of standards in the premarket process. Used this way, conformity to FDA recognized consensus standards will reduce the amount of documentation that you need to submit and may allow FDA to reduce review time.

Applicants referencing a national or international standard should include a completed Standards Data Form for 510(k)s (FDA Form #3654, Form Approved OMB #0910-0120) as part of their 510(k).