Guidance Seeks to Unify IEC, FDA Standards for X-Ray Devices

The FDA is attempting to harmonize performance standards with International Electrotechnical Commission standards for certain x-ray imaging devices.

The agency hopes to streamline the review process by providing recommendations on how devicemakers may meet FDA standards by conforming to IEC standards.

The agency said in draft guidance released Aug. 3 that it believes conformance to certain IEC standards would provide the same level of or improved protection from electronic radiation as Electronic Product Radiation Control (EPRC) regulatory standards. — Tamra Sami