We would welcome further expansion of the information exchange to meet performance standards, as such would not appear to be "trade secrets" or "confidential information" but rather consistent with addressing appropriate servicing of a device.

The FDA is to be commended for the publication of this draft guidance on Radiation Control of Diagnostic X-Ray Equipment, as well as for undertaking this month the Workshop on Servicing and Remanufacturing. However, as recently observed from manufacturers and servicers input at the Workshop, there are very difference vantages, firmly held, as to what constitutes "adequate instructions" and what "level of access" should be permitted to device information. This is particularly important with regard to software.


Further elaboration of what constitutes access to "operating" software and what constitutes "servicing software" seems warranted. A fuller explanation of what may constitute "trade secrets" and how software systems may be segregated (if at all) also would go a long way to obviating ambiguity in this area.

Further, it would seem that one would not be invading "trade secrets" by simply accessing a diagnostic system’s "user manual and/or trouble shooting guide" and the same should be made readily available. Accordingly, greater elaboration of these areas seems appropriate for the final Guidance.

The 44-page FDA Guidance is an important effort by the FDA to clarify areas of ambiguity and stakeholders are well advised to use the next sixty days to offer their further input. Dissemination of the above should also occur for all other regulated devices. Comments concerning the draft document must be submitted to the FDA Dockets Management Staff by February 15, 2019.

About the author: Robert J. Kerwin is general counsel for IAMERS, the International Association of Medical Equipment Remarketers and Servicers.
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