The U.S. Food and Drug Administration has set this coming Friday, January 25, 2019 as the deadline for submitting written comments to the FDA docket in connection with development by FDA of a guidance for Medical Device Servicing.
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 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.