Which statement about SMDA reporting is true?

Which statement about SMDA reporting is true?

• A. SMDA incidents must be reported to the FDA and the manufacturer
• B. SMDA incidents must be reported to the CMS
• C. SMDA incidents must be reported to local health department
• D. SMDA incidents do not require reporting

Answer: (A)

Under SMDA, when there is a device-related death or serious injury, the facility using the device must report the event to both the FDA and the device manufacturer. This dual reporting ensures regulatory oversight and prompt manufacturer investigation and corrective action. Reporting to CMS or a local health department isn’t the mandated path for SMDA device-adverse events, and there is indeed a requirement to report.

Under SMDA, when there is a device-related death or serious injury, the facility using the device must report the event to both the FDA and the device manufacturer. This dual reporting ensures regulatory oversight and prompt manufacturer investigation and corrective action. Reporting to CMS or a local health department isn’t the mandated path for SMDA device-adverse events, and there is indeed a requirement to report.