The U.S. Department of Health and Human Services (DHHS) Food and Drug Administration Agency (FDA) is seeking small business sources to support program efforts to extend the shelf life of stockpiled medical devices.
The selected contractor will help FDA personnel develop concepts and principles of accelerated and real-time testing, storage conditions, labeling, or other factors that may be important for FDA to consider for this project.
A written report identifying existing shelf-life programs, regulations, guidance, and standards that may be relevant to medical device shelf life must be provided, as well as an analysis of the utility of the existing programs for use in medical devices.
The contractor will also produce a report outlining an adequate shelf-life program necessary to support a long-term shelf life claim of a stockpiled medical device. Where recommendations may rely on accelerated test methods, the report shall identify adequate test methods and their validity for project devices, a description of test methods including necessary references, and identification of endpoints or endpoint analysis process.
Further details are available under Solicitation Number: Solicitation Number: FDA-SS-1134670. The response deadline is July 17, 2014.
