FDA Oversight Of Medical Products Remains A "High-Risk" Concern For GAO
This article was originally published in The Pink Sheet Daily
Executive Summary
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.
You may also be interested in...
Drug Shortage Oversight Remains Key GAO Concern As FDA Is Again Deemed “High-Risk”
Report again calls for improvement in oversight of medical device recalls by FDA, as well as for increased inspections of foreign establishments that make medical products for the U.S. market.
FDA Long-Term Globalization Strategy Under Development
Coping with an increasingly global device and drug industry will require a paradigm shift that relies less on FDA's own staff and more on data and resource sharing with other countries, the agency says.
GAO “High-Risk List” Urges Enhanced FDA Oversight Of Medical Products
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