FDA Aligns Select Standards with IEC

The FDA has released a guidance document proposing conformance with certain International Electrotechnical Commission (IEC) regulatory standards, intended to streamline the review process for diagnostic x-ray systems. Device manufacturers could fulfill Electronic Product Radiation Control (EPRC) or 510(k) requirements by meeting the equivalent IEC standards and submitting a letter of conformity.

The FDA believes the IEC standards will provide the same or improved levels of protection as the EPRC, while consolidating the information manufacturers submit to the FDA. 

“Declaration(s) of conformity to recognized consensus standard(s) could be sufficient to eliminate the need for manufacturers to submit in their 510(k) (and for FDA to review) the actual test data,” the FDA said in its draft guidance.

The majority of the devices addressed by the guideline are diagnostic x-ray systems and CT equipment. The list of devices that are able to fulfill 510(k) requirements with IEC standards is much shorter, although it includes common equipment like collimators. Some EPRC device categories have no comparable IEC standard, such as warning labels and identification of x-ray components.

The full release from the FDA is available here.