An editorial by Robert J. Kerwin
The U.S. Food and Drug Administration has extended the deadline for submitting written comments to its docket concerning guidance for Medical Device Servicing. Initially set for Friday, January 25, 2019, the FDA is adding an extra month for stakeholders to make their voices heard, closing the docket on February 25.
The FDA request for comments follows publication by FDA, in the fall 2018, of a white paper on "Servicing vs. Remanufacturing"
and a two-day December FDA Workshop in Gaithersburg, Maryland.
Video recordings of the December meeting have been made available
on the FDA website.
The FDA docket to which servicing comments may be uploaded, can be found here
and should be identified as pertaining to FDA Docket 2018-N-3741.
The servicing guidance is expected to address what constitutes "remanufacturing" versus "servicing", as this was an area identified by FDA in its May 2018 Report as a subject of confusion among stakeholders. Moreover, this distinction is of importance to the day-to-day activities of servicers. To what extent will a repair of a device or a part be determined to be remanufacturing? Should an activity be determined to be "remanufacturing", the regulatory requirements imposed on manufacturers would likely apply.
The FDA Guidance is also expected to address other areas of substantial dispute between servicers and manufacturers. Among other things, it is expected that FDA will further explain manufacturer labeling requirements and what constitutes adequate device instructions. What constitutes "integral" manufacturer software, which must be provided? Is the FDA’s interpretation of what constitutes "adequate instructions" limited to delivery of a service manual? Can a manufacturer claim certain information constitutes "trade secrets" exempt from delivery to servicers, when this information may be necessary to comply with manufacturer obligations to provide adequate instructions?
Guidance documents are often prepared by governmental agencies to interpret existing laws and regulations in light of technological developments and reported areas of confusion. For 40 years there has been ongoing confusion over the extent to which manufacturers must provide information to those who service devices and who are not employed by the manufacturer.
If the servicing of devices is truly about patient safety, critical device information should not be withheld on the grounds of trade secrets. Moreover, questions exist under applicable trade secret law as to whether the information is truly "trade secret" information if it is provided to some servicers but not other servicers. Is it really secret? Patient safety and pragmatism should control.
IAMERS is requesting that the FDA resolve confusion with respect to FDA’s interpretation of what constitutes the scope of "adequate instructions" particularly with respect to access to service keys, technical information and updates. What, if any, consequences should exist if the manufacturer declines to cooperate?
A manufacturer should not be able to claim that certain necessary instructions will not be provided because the manufacturer claims the information otherwise provided is a "trade secret", or the equipment has reached "end of life" status (a condition determined ahead of time by the manufacturer). Since all of the leading manufacturers engage in multi-vendor servicing programs for healthcare organizations, they, themselves, experience issues with the dearth of information being willingly provided, when they attempt to service devices other than those they manufacture.
The industry, and most importantly the patients, benefit from cooperation in this area. Where policing this area is, as at least one manufacturer has suggested, within the "exclusive" jurisdiction of FDA, we will be very interested in learning how the FDA intends to further address noncompliance with existing regulatory requirements for adequate instructions.
We are grateful to the FDA for its very substantial efforts to receive industry input (including the full participation of senior CDRH leadership in both days of the 2-day workshop). Still, as noted, there are many important questions we are hopeful the answers to which should be clarified in the FDA Servicing Guidance.
Your input is essential. Moreover, while the FDA is in the process of updating certain aspects of servicing, such as its guidance on radiation control regulations (comments to which are due February 15, 2019) it may, as a practical matter, be several years before the FDA formally revisits this servicing guidance area.
About the author: Robert J. Kerwin is general counsel for IAMERS, the International Association of Medical Equipment Remarketers and Servicers.