FDA Shares Two Guidance Documents for Imaging Providers
May 2019 ~
The FDA has published two new guidance documents, titled “Medical X-Ray Imaging Devices Conformance with IEC Standards” and “Policy Clarification for Certain Fluoroscopic Equipment Requirements,” separately define the agency’s regulatory standards for medical imaging equipment and have been designed to align the agency’s requirements for x-ray imaging devices with various international standards.
The Medical X-Ray Imaging Devices Conformance with IEC Standards is related to the regulation of x-ray solutions subject to the Federal Food, Drug & Cosmetic Act (FD&C Act) and is intended to align the Electronic Product Radiation Control (EPRC) subchapter of the FD&C Act for X-ray imaging equipment with the International Electrotechnical Commission (IEC). The document also provides recommendations for manufacturers on how to comply with the requirements and recommendations for vendors to help them comply with IEC requirements. According to the FDA, these standards will “help ensure more efficient and consistent regulatory review of submissions for these products.”
“Manufacturers and importers of medical x-ray imaging equipment must follow the current EPRC regulations and procedures or provide a declaration of conformity to equivalent IEC standards, as outlined in this guidance, to fulfill the requirements of the EPRC regulation,” according to a statement from the FDA. “Using a declaration of conformity to equivalent IEC standards reduces duplication of efforts by manufacturers and allows FDA to provide more efficient and consistent regulatory reviews of submissions relating to medical x-ray imaging devices.”
The Policy Clarification for Certain Fluoroscopic Equipment Requirements defines standards for fluoroscopic equipment and includes language intended to clarify the FDA’s interpretation of certain aspects of the performance standard requirements in 21 CFR 1020.30 and 1020.32 for fluoroscopic equipment.
The 6-page guidance finalizes a draft from September 2014 and addresses three aspects of the federal performance standard for fluoroscopic equipment: Fluoroscopic Irradiation Time, Last-Image Hold and Emergency Fluoroscopy Mode.