FDA Touts Record PMA Approval, Ebola Response and Fighting Duodenoscope Issue
FDA Acting Commissioner of Food and Drugs Stephen Ostroff, M.D. is clearly pleased with the work that the agency accomplished last year. In a series of FDA 2015 blogs, Ostroff called out several key achievements in 2015:
- Since 2009, the average PMA decision time has gone down 36%
- Record approval for devices under original premarket approval pathway hits 58
- More patient involvement in the device innovation process with the launch of the Patient Engagement Advisory Committee
- Launch of cloud-based precisionFDA web platform to enable collaboration between partners and scientists in industry, academia and government in developing next-generation sequencing tests
- Collaborative response to the Ebola virus—bringing together partners in government, drug and diagnostic companies, and global groups such as the World Health Organization to quickly provide diagnostic tests, therapeutics and vaccines to West Africa
- Raising awareness of transmitted, including antibiotic-resistant, infections from duodenoscopes via safety communications and working with device manufacturers via recommendations on reprocessing of the products. The agency also issued warning letters to three duodenoscope manufacturers as a result of violations found during inspections
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