Workshop on 3rd Party Medical Device Refurbishing

Federal Register Notice: FDA will hold a public workshop 10/27-28: “Refurbishing, Reconditioning, Rebuilding, Remarketing, Remanufacturing, and Servicing of Medical Devices Performed by Third-Party Entities and Original Equipment Manufacturers.” The workshop will discuss the current regulatory environment for these activities, the definitions of the various terms FDA proposed in the prior Federal Register notice on this subject, and whether these activities should appropriately be regulated by FDA or a non-governmental organization. The workshop will be held 10/27, from 8:30 a.m. to 5 p.m. and 10/28, from 8:30 a.m. to 4 p.m. at FDA’s White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD. Contact Felicia Brayboy, (301) 796-8086, Felicia.Brayboy@fda.hhs.gov. To view this notice, click here.