An editorial by Robert J. Kerwin
On December 17, 2018, the FDA published a draft guidance in the Federal Register for industry and FDA staff that addresses, among other things, manufacturer responsibilities to provide adequate instructions to undertake compliant installations of diagnostic X-ray systems, including access to operating software.
The Guidance, entitled “Clarification of Radiation Control Regulations For Manufacturers of Diagnostic X-Ray Equipment”
, also addresses general labeling, record-keeping, product reports and additional assembly requirements. When final, the Guidance will supersede the FDA Guidance issued in 1989.
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A federal agency "guidance" is frequently a compilation by which it updates agency interpretations of existing regulations and guidances as well as applicable law in light of industry developments. Since the 1989 FDA Guidance was first issued there have been many advances including the expansion of software for device operations and the widespread use of service keys and cybersecurity protections.
The draft guidance addresses only the requirements that apply to diagnostic X-ray equipment under the electronic products section known as the Emitting Products Electronic Product Radiation Control Program (EPRC). FDA has advised in that connection that it intends to amend its performance standards to harmonize many of its requirements with those of the International Electrotechnical Commission standards.
Providing instructions to assemblers, purchasers and others
An area of frequent concern is access to adequate instructions. The guidance provides that adequate instructions must be provided by which the specific technical specifications of the equipment and any necessary radiological safety precautions may be disclosed. Manufacturers of components listed in 21 C.F.R. 1020.30(a)(1) are required to provide assemblers with these instructions at a cost not to exceed the cost of publication and distribution.
The guidance notes that the instructions to be supplied by the manufacturer must “provide specifications for other components that are compatible with the component to be installed when compliance with the component or system depends upon compatibility.” The specifications may describe physical characteristics of compatible components and/or may list, by manufacturer’s name and model designation, specific components that are compatible, consistent with 21 CFR 1020.30(c) and 1020.30(g).