Clinical Study Service Contract

The Clinical Study Service Contract is a forecast initiative managed by the Food and Drug Administration. This program is designed to support the strategic priorities of the Center for Devices and Radiological Health by allowing medical device sponsors to utilize existing public datasets for regulatory validation. By leveraging this data, the agency aims to decrease the need for expensive and duplicative clinical studies. A primary goal of this initiative is to lower the barriers associated with validating medical devices intended for underrepresented populations. Interested parties can coordinate with the CDRH Acquisition Liaison regarding this opportunity, which is categorized under NAICS code 111332.