Since December 13, 1984, the FDA Medical Device Reporting (MDR) regulations have required firms who have received complaints of device malfunctions, serious injuries or deaths associated with medical devices to notify FDA of the incident. The Safe Medical Devices Act (SMDA) of 1990 provided FDA with two additional postmarketing activities, Postmarket Surveillance for the monitoring of products after their clearance to market and Device Tracking for maintaining traceability of certain devices to the user level.
- different time frames for reporting
- use of standardized reporting forms
- removal of unanticipated temporary impairments
- new definitions
- addition of an FDA disclaimer
- removal of the "per se" rule
For more information, please call us at (855) 541-2862 or send an email to info@medsol.com.
