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Global Certification Technical Update

August 2019

August 2019 Updates

US

US (FDA) – Issues Guidance on Conformity of Medical X-Ray Devices with International Standards

Effective May 8, 2019

 

The US Food and Drug Administration (FDA) has issued the guidance document regarding X-ray devices designed to more closely align FDA requirements with internationally developed standards.

 

Medical X-Ray Imaging Devices Conformance with IEC Standards:

 

This guidance describes FDA’s policy regarding the regulation of medical X-ray imaging equipment that is subject to the Federal Food, Drug & Cosmetic Act (FD&C Act) and FDA’s regulations that apply to medical devices and electronic products.

 

The FDA is seeking to harmonize performance standards prescribed by Electronic Product Radiation Control (EPRC) of the FD&C Act with IEC standards. The Guidance also provides recommendations to industry on how to comply with the applicable requirements. The FDA has determined that industry conformance to certain IEC standards would provide, at a minimum, the same level of protection of the public health and safety from electronic radiation as certain EPRC regulatory standards.

 

Manufacturers and importers of medical X-ray imaging equipment must follow the current EPRC regulations and procedures or provide a declaration of conformity to the equivalent IEC standards, as outlined in this Guidance, to fulfill the requirements of the EPRC regulation. Using a declaration of conformity to the equivalent IEC standards reduces duplication of efforts by manufacturers and allows the FDA to provide more efficient and consistent regulatory reviews of submissions relating to medical X-ray imaging devices.

 

US (DOE) – Energy Conservation Standards for Dishwashers, Grant of Petition for Rulemaking

Proposed date of entry into force: To be determined

 

The U.S. Department of Energy (DOE) received a petition from the Competitive Enterprise Institute (CEI) to define a new product class under the Energy Policy and Conservation Act, as amended (EPCA), for residential dishwashers. The new product class would cover dishwashers with a cycle time for the normal cycle of less than one hour from washing through drying. DOE published this petition and request for comments in the Federal Register on April 24, 2018. Based upon its evaluation of the petition and careful consideration of the public comments, DOE has decided to grant this petition for rulemaking and propose a dishwasher product class with a cycle time for the normal cycle of less than one hour. DOE intends to consider appropriate energy and water use limits for such a product class, if adopted, in a separate rulemaking.

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