In order to effectively receive clearance (via the 510(k) process) or approval (via the Premarket Approval – PMA process) for your medical device for commercial release within the United States it is important to understand the organization of the Food and Drug Administration (FDA). The office of the FDA that is responsible for the safety and effectiveness of medical devices is the Center for Devices and Radiological Health (CDRH). The Office of the Center Director is the head of this department and
coordinates the efforts of the seven offices below it. Each office is responsible for a different aspect of
the clearance and/or approval process and ensuring that the proposed devices are safe and effective on the market in the United States.
The Offices of Device Evaluation and In Vitro Diagnostic Device Evaluation and Safety have the
responsibility for reviewing the pre-market applications (including the 510(k) and PMAs), each office
evaluating devices within their area of expertise. The Office of Science and Engineering Laboratories
will perform lab testing, if applicable and warranted. The Office of Communication, Education,
and Radiation Programs will provide education to the FDA staff of this department. The Offices of
Compliance and Surveillance and Biometrics ensure the continued safety of devices (working with MDRs
– Medical Device Reportable events such as deaths and serious injuries associated with commercially
released medical devices within the United States) once they are placed on the market.