Under the Safe Medical Devices Act of 1990, facilities must file medical device reporting how often?

• A. Monthly MDR
• B. Semiannual and annual MDR
• C. One-time MDR
• D. No MDR required

Answer: (B)

MDR reporting cadence under the Safe Medical Devices Act of 1990 is semiannual and annual. This framework was put in place to ensure ongoing postmarket surveillance by collecting device-related death and serious injury information over time, rather than requiring monthly submissions or a one-time report. It also avoids unnecessary burden while keeping FDA informed with regular, comprehensive data. Therefore, the correct approach is to submit reports on a semiannual basis and provide an annual summary.