This is a time and materials contract award to Pn-Heitech, LLC, a minority-owned small business, by the Food and Drug Administration (FDA) for medical device reporting (MDR) services in support of the Center for Devices and Radiological Health (CDRH). The contract has a ceiling value of $34,624,137.73 and a period of performance through September 29, 2025. Pn-Heitech provides a range of services to the FDA, including help desk support, records management, Freedom of Information Act assistance, and device registration. This award is part of a larger Indefinite Delivery Contract vehicle with the FDA valued at up to $103 million, which has supported IT functions, medical device regulatory responsibilities, and records modernization efforts through firm fixed price and labor hour task orders. No subcontractors or set-aside designations were indicated in the information provided.
Generated 12/17/24, 9:34 AM