The guidance also notes that manufacturers of X-ray equipment are required to provide purchasers, and upon request to others, manuals or instruction sheets with the information required under 21 C.F.R. 1020.30(h).
The draft guidance has been issued mostly in a question and answer format. It clarifies some manufacturer responsibility areas. However it also leaves open to further interpretation certain important areas, such as software availability.
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While the Guidance document acknowledges that “if software is required to assure a compliant assembly, the manufacturer is required to provide the software”, the guidance document also provides that “some manufacturers have developed proprietary software beyond that required by 21 C.F.R. 1020.30(g) for use as an aid during the assembly process. They are not required to provide such ancillary software.” The guidance document provides, as a footnote, that additional information is available in the FDA’s 2003 guidance entitled “Information Disclosure by Manufacturers to Assemblers For Diagnostic X-Ray Systems”
From speaking with some experienced servicers, it is not clear whether or not manufacturers will interpret these guidance provisions to ensure that the servicer is able to fully calibrate and adjust an X-ray system for use by the customer in a proper manner. If the purpose of the guidance and applicable FDA regulations is to ensure that a radiation emitting device may be properly serviced, an elaboration seems appropriate.
Not required to share repair information with users and others
Among the areas for which third-party servicers may expect continued challenges, are appropriate interpretations of what information constitutes "adequate" instructions and what information constitutes "trade secret" information, for which the manufacturer will claim no obligation to produce. Though the draft guidance restates the long-required regulatory obligations of the manufacturer to “provide the assembler and others who request it, at a cost not to exceed the cost of publication and distribution, with adequate instructions for assembly, installation, adjustment and testing of the component to assure the product will comply with the Performance Standards when instructions are followed”, there appear to be no consequences outlined when a manufacturer declines to comply.
In response to a question framed as “[a]re manufacturers required by the Performance Standards to provide maintenance and repair instructions to users or others,” the FDA Guidance provides a response in the negative and offers by way of explanation “The Performance Standards only require manufacturers to provide a schedule of maintenance (if any) necessary to maintain compliance with Performance Standards (21 CFR 1020.30(h)(1)(ii).” For further direction, the FDA again references the 2003 Guidance entitled “Information Disclosure by Manufacturers to Assemblers for Diagnostic X-Ray Systems
If there are specifications or performance standards of subsystems or components that would only be measured or quantified during the course of corrective or scheduled maintenance and not necessarily required for installation, those specifications should also be shared. In the same vein, with regard to specifications required only in the course of component replacements those specifications should be provided and the guidance ought to specifically address this requirement. Consistent with the above, if, in the manufacturer’s scheduled or preventive maintenance instructions, there exist requirements for the periodic maintenance scheduled components based on aging (time in service) or specifically denoted and measurable degrees of wear, then that information should be shared.