GAO “High-Risk List” Urges Enhanced FDA Oversight Of Medical Products
This article was originally published in The Gray Sheet
Executive Summary
The Government Accountability Office added enhanced oversight of devices, drugs and other medical products to its list of "high-risk" priorities in a report to Congress released Jan. 22
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Resource management and strategic planning, mounting challenges associated with globalization, oversight of post-market product safety, and the agency's efforts to address devices that are class III but continue to reach the market through the 510(k) pathway top GAO's list.
FDA Oversight Of Medical Products Remains A "High-Risk" Concern For GAO
The Government Accountability Office is once again listing FDA's ability to ensure the safety and effectiveness of devices, drugs and other medical products on its roster of "high-risk" concerns.