The 2025 CDRH Annual Report provides a comprehensive overview of the Center’s continued progress in balancing the review of new medical technologies with the rigorous oversight of patient safety. This latest update shows the FDA meeting its commitment to predictable regulatory pathways, ensuring that both manufacturers and patients can rely on consistent standards of excellence. The CDRH continues to refine its established processes to meet the demands of a modern healthcare landscape.
The 2025 report highlights a period of sustained operational performance, focusing on several core areas that define the Center’s current trajectory. The CDRH continues to manage a high volume of novel medical device authorizations, maintaining the momentum required to bring diverse technologies to the clinical environment. Building on years of foundational work, the Center has further integrated digital health frameworks. This includes the implementation of the TEMPO (Technology-Enabled Meaningful Patient Outcomes) pilot, designed to evaluate digital tools through a structured, data-driven approach. A significant focus remains on ensuring the United States is a primary destination for medical innovation. The report notes that a majority of manufacturers continue to prioritize the U.S. market, facilitated by the Center’s efforts to align with international regulatory standards. The report underscores the effectiveness of the Center’s “Early Alert Program.” By meeting consistent benchmarks for identifying and addressing safety signals, the CDRH maintains its role as a proactive guardian of public health.
The 2025 report does not represent a shift in direction, but rather the successful execution of the 2022–2025 Strategic Priorities. For the past several years, the CDRH has focused on three stable pillars: promoting a modern and agile workforce, enhancing organizational transparency, and advancing health equity through clinical trial diversity.
In 2023 and 2024, the Center focused on stabilizing its infrastructure following the pandemic-era workload. The 2025 report demonstrates the maturity of those efforts, showing how the Total Product Life Cycle (TPLC) approach has become a standard operating procedure. While previous years established the “what” and the “why” of these strategies, the 2025 report documents the “how”, providing evidence that these multi-year initiatives are yielding predictable, measurable results in device safety and market access.
The CDRH 2025 Annual Report serves as a record of continuity, steadiness, and incremental progress within the FDA’s medical device programs. It confirms that the Center’s long-term strategic goals are being met through disciplined adherence to established regulatory frameworks.
