The FDA will also be exploring which device specs should be included in the device labeling and which should be confidential commercial information protected from public disclosure. Among the areas to be explored include "whether there are additional component/part/material specifications that should be included in labeling to facilitate high-quality, safe and effective servicing'.

Specifically, the FDA asks: "is there any additional information about software that should be included in labeling?" The FDA provides examples to be discussed at its workshop with respect to, among others, MR, ultrasound devices and circuit boards. The FDA also seeks insight on components that may have a defined "intended use life", and the nature of activities performed to extend the device’s intended use life. Also likely to be addressed are issues raised with respect to malfunctions and repair issues when addressing the battery of a reusable device.


The FDA has advised of its intention to publish a guidance following the workshop and the comments received in the docket. The addendum to the white paper sets forth definitions of important terms such as remanufacturing, refurbishing and service from the FDA Report on Device Servicing, which ought to be reviewed before commenters submit their thoughts to the docket.

The public workshop will take place at the Hilton Washington D.C. North Gaithersburg Hotel from 8 am to 5 pm on Monday, December 10 and from 8 am to 12 pm on Tuesday, December 11. Registration can be completed here. Participation will also be made available via web access, which can be chosen during registration.

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

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