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What has always been implicit in the FDA’s Quality System Regulation is spelled out in detail in the 2016 version of international standard ISO 13485. Read More
Final guidance on reducing cross-contamination from irrigation valves and accessories for flexible gastrointestinal endoscopes adds a new section on testing for backflow prevention. Read More
Industry representatives have endorsed measures that would streamline the FDA’s premarket review process, but said they will be watching closely for tangible results in exchange for a $320 million increase in user fees. Read More