FDA Looks To Reduce Regulatory Duplication With Draft X-Ray Guidance

Some manufacturers and importers of X-ray imaging devices may avoid 510(k) reporting requirements if their product conforms to certain International Electrotechnical Commission (IEC) standards, according to a new US FDA draft guidance. The agency says it is trying to address complaints from manufacturers about duplicate reporting of X-ray products that need to meet its 510(k) premarket notification requirements and Electronic Product Radiation Control (EPRC) reporting.

"Conformance with recognized consensus standards may in some situations support a substantial equivalence determination," states the guidance. "Moreover, declaration(s) of conformity to recognized consensus standard(s) could be sufficient to eliminate...