Regulatory policies set forth in 1989 for manufacturers of diagnostic x-ray equipment were substantially updated via new US Food and Drug Administration (FDA) draft guidance released last Friday.
The new 44-page draft guidance aims to provide clarifications on certain regulations created under the Radiation Control for Health and Safety Act of 1968
(RCHSA) that are enforced by FDA’s Center for Devices and Radiological Health (CDRH). The updates come nearly three decades after RCHSA provisions were incorporated into the FD&C Act
via the Safe Medical Device Act of 1990
to replace guidance issued
RCHSA provisions pertaining to the record-keeping, reporting, manufacturing, importing and installation of “electronic products” are now covered also in Subchapter C: Electronic Product Radiation Control (EPRC) of the FD&C Act
, FDA noted. This is because diagnostic x-ray systems are considered to be both medical devices and electronic products, though the new draft guidance does not cover medical device-specific requirements under provisions of the FD&C Act
The draft guidance addresses the EPRC provisions for revised requirements on diagnostic x-ray systems as electronic products and refers to the provisions as “performance standards” for the purposes of CDRH oversight of manufacturers, importers, dealers, distributors and assemblers.
“Manufacturers of diagnostic x-ray systems should be aware that CDRH intends to amend FDA’s performance standards, as appropriate, to harmonize many of its requirements with those of the International Electrotechnical Commission (IEC) standards because FDA acknowledges the importance of simplifying compliance for global manufacturers,” FDA said. It recently formed
a partnership with IEC through its participation in the International Medical Device Regulators Forum.
The information contained in the draft guidance is separated into two main sections, including general information regarding diagnostic x-ray equipment and the more lengthy Q&A section with specific information.
Manufacturers of diagnostic x-ray systems “must maintain records and provide reports to FDA” and “include a label or tag permanently affixed to their electronic products that identify the manufacturer, location and date of manufacture and state that the products are certified,” FDA said. Other general requirements relate to certification of compliance on x-ray system components and providing assemblers with instructions for components’ assembly, installation, adjustment and testing as well as technical and safety specifications to equipment purchasers.
Specific “topics of importance to manufacturers” of diagnostic x-ray equipment include labeling, measurements, models, assembly, accidental radiation occurrence, defects, fluoroscopy and components, such as filters and timers, among others, according to the draft guidance.
Clarification of Radiation Control Regulations For Manufacturers of Diagnostic X-Ray Equipment: Draft Guidance