Sentinel: Sentinel System 3.0 IDIQ

FDA is launching the new Sentinel 3.0 System in fiscal year 2026 based on 1) FDA's experience using the Sentinel 2.0 System, BEST Initiative, and Medical Device Active Surveillance, 2) the foundational work conducted by both the Sentinel 2.0 Innovation Center and BEST programmatic work using EHR data linked to administrative claims data during the 2019 to 2025 contract cycle, 3) the guidance provided by CDER, CBER, and CDRH Senior Leadership, 4) input received through responses to four Requests for Information (RFI) related to the Sentinel 3.0 System recompete,10 and 5) input received from the public through questions and comments received by FDA after the 2024 16th Annual Sentinel 3.0 Initiative Public Workshop. (1) FDA Sentinel Coordinating Center (SCC): The SCC will be managed by the Sentinel 3.0 Core Team (SCT) in CDER's OSE, in the OBPV's Surveillance Program Staff (CSPS), in CDRH's Office of Clinical Evidence and Analysis (OCEA), and Office of the Commissioner (OC). (2) Sentinel Program Management Organization (PMO): The PMO, via a contract awarded in September 202412, provides program/project management and business informatics support services (e.g., Collaboration Platform that operates outside of FDA in a Federal Risk and Authorization Management Program (FedRAMP) cloud-based environment). (3) Data Hub and Scientific Support Services: The Data Hub, comprising Data Partners and the Data Platform, along with Scientific Support Services