CDRH request for proposal
This article was originally published in The Gray Sheet
Executive Summary
RFP recently posted on the agency's website solicits contractor for "ad hoc research, engineering and studies" related to medical devices and radiation-emitting electronic products, including the development of instrumentation, calibration capabilities and analytical procedures. The device center's Office of Health and Industry Programs intends to obtain from the selected contractor a "commensurate level of data, analytical procedures, or specialized instrumentation sufficient for the generation of meaningful data to facilitate" FDA's review of the products. Responses to the RFP are due June 14