510(k) Clearances
Carbapenem-Resistant Enterobacteriaceae (CRE)
Endoscope Reprocessing
Endoscopic Retrograde Cholangiopancreatography (ERCP)
Food and Drug Administration
Food Drug and Cosmetic Act
Medical Device Reports (MDRs)
Ted Lieu
USA Today
USA TODAY Investigation: “Reports to Feds on deadly bacteria outbreaks arrived late”
Medical device reports — or, MDRs, which manufacturers of duodenoscopes and other medical devices are required to submit to the FDA within 30 days of learning that their device might…