Friday, March 9, 2018

US FDA News: FDA warns duodenoscope manufacturers about failure to comply with required postmarket surveillance studies to assess contamination risk

FDA has issued warning letters to Olympus, FujiFilm and Pentax, for failing to comply with section 522 orders on postmarket surveillance studies for duodenoscopes
Read more: FDA warns duodenoscope manufacturers about failure to comply with required postmarket surveillance studies to assess contamination risk