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FDA Releases Reports on Medical Device Safety Initiatives

The Center for Devices and Radiological Health (CDRH) at the U.S. Food and Drug Administration (FDA) has released its latest reports on the agency’s activities in support of the safety and innovation of medical devices.

Issued in mid-April, the “2024 CDRH Safety Report” is a 10-page slide deck highlighting the agency’s recent and current efforts to support its regulatory vision for medical devices, that is, ensuring that “Patients in the U.S. have access to high-quality, safe, and effective medical devices of public health importance first in the world.”

Specific CDRH activities addressed in the Safety Report include: 1) enhancing manufacturing quality; 2) strengthening post-market surveillance; 3) increasing data transparency; 4) strengthening medical device recall programs; and 5) executing the agency’s medical device safety action plan.

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How to Perform a Radiated Emissions Measurement

Radiated emissions testing is the measurement of the electromagnetic field of the emissions that are unintentionally being generated by the equipment under test.

The release of the 2024 Safety Report is concurrent with the release of the “2024 CDRH Innovation Report,” which addresses: 1) encouraging innovation; 2) increasing regulatory flexibility; 3) partnering with patients and stakeholders; and 4) collaborating with innovators.

Read the CDHR’s 2024 Safety Report.

Read the CDRH’s 2024 Innovation Report.

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