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Washington Democratic Sen. Patty Murray is demanding answers from the leaders of three device companies at the center of an ongoing FDA investigation of contaminated duodenoscopes that regulators worry are spreading deadly bugs. Read More
Two manufacturers selling three surgical mesh products did not conduct a sufficient assessment of their devices’ long-term safety, the agency said. Read More
Two breast implant manufacturers were served with warning letters after the FDA found they failed to comply with post-approval study requirements. Read More