The Food and Drug Administration (FDA) is announcing a public Workshop entitled “Refurbishing, Reconditioning, Rebuilding, Remarketing, Remanufacturing, and Servicing of Medical Devices Performed by Third-Party Entities and Original Equipment Manufacturers.” The topics to be discussed are the current regulatory environment for these activities, the definitions of the various terms FDA proposed in our prior Federal Register notice on this subject, and whether these activities should appropriately be regulated by FDA or a non-governmental organization. On March 4, 2016, the FDA opened a docket to request comments from individuals and organizations engaged or otherwise interested in the Refurbishing, Reconditioning, Rebuilding, Remarketing, Remanufacturing, and Servicing of Medical Devices, including radiation-emitting devices subject to the electronic product radiation control provisions of the Federal Food, Drug, and Cosmetic Act. FDA took this action, in part, because various stakeholders have expressed concerns about the quality, safety, and continued effectiveness of medical devices that have been subject to one or more of these activities. This docket asked that Original Equipment Manufacturers (OEMs), health care establishments and third-party entities review proposed terms and definitions and provide edits if applicable. The docket also sought insights into basic concepts with regard to these activities. (View the docket and public comments)
The purpose of the workshop is to convene interested parties to discuss regulatory aspects of third party processes: refurbishing, reconditioning, rebuilding, remarketing, remanufacturing servicing and address ‘Working Questions’ that the FDA designed from the comments made to the docket, to promote understanding of challenges and best practices to mitigate risks associated with these activities.
- Date, Time and Location
- Federal Register Notice
- Registration
- Contact Us
FDA Campus Information
The meeting will be webcast (general sessions only).
[email protected].
For questions regarding workshop content please contact:
Felicia Brayboy, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave, Bldg. 66, Room 5625, Silver Spring MD 20993, 301-796-8086, [email protected]
For questions regarding workshop content please contact:
Felicia Brayboy, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave, Bldg. 66, Room 5625, Silver Spring MD 20993, 301-796-8086, [email protected]