Article Title: FDA’s Tarver says agency open to improvement of third-party reviews
Publication Date: Thu, 01 May 2025
In a recent trade association meeting on May 1, 2025, Michelle Tarver, director of the FDA’s Center for Devices and Radiological Health (CDRH), indicated the agency’s willingness to refine its procedures for third-party reviews.
The information, originating from the meeting, suggests the FDA’s openness to receive feedback and adapt its existing systems for the improvement of third-party reviews. The intention of these considerations is expected to bolster the existing processes at the CDRH. Dr. Tarver also gave an overview of various programmatic areas, including the early alert program managed by the CDRH.
Regarded as an integral component of the FDA, the CDRH is responsible for approving, monitoring, and enforcement activities for medical devices and radiological products. Consequently, any changes in its operational procedures can significantly impact the industry at large.
The strategic implication of improved third-party review processes could lead to swifter reviews and approvals of medical devices and radiological products. This scenario can potentially lead to increased supply in the market, and may foster increased innovation as companies may be motivated to expedite the product development process. On the flip side, investors should also be mindful of potential risks, such as the possibility of overlooking issues during expedited reviews, leading to potential product recalls and reputational damage. Deeper diligence on the nature of any procedural changes, and their potential impact on specific companies or products, will be important for strategic planning and investment decisions.
Investors, industry executives, and decision-makers should keep a close eye on this development and assess the potential impact on their respective businesses or investments. The Industry Informant platform will continue to monitor and report on significant updates around this evolving situation. Trust us as your reliable partner for insightful biotech market intelligence.
