Adverse Event Reports
Food and Drug Administration
Food Drug and Cosmetic Act
Informed Consent
Medical Device Reports (MDRs)
Misbranded Devices
Patient Notification
Warning letters (FDA)
Hundreds of Thousands of Device Reports Were Submitted Late to FDA, a New Study Has Found, Raising Safety Questions
Hundreds of thousands of reports from device manufacturers describing an adverse event during a recent 3-and-a-half-year period were submitted to FDA late, a March study has found, raising questions about…