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AdvaMed Comments on Servicing of Medical Devices Performed by Third-Party Entities

first page of AdvaMed Comments on Servicing of Medical Devices Performed by Third-Party Entities

AdvaMed submitted these comments in response to the Food and Drug Administration’s (FDA’s) Federal Register Notice requesting comment on refurbishing, reconditioning, rebuilding, remarketing, remanufacturing and servicing of medical devices performed by third-party entities and original equipment manufacturers. AdvaMed’s members manufacture and service their own products as original equipment manufacturers (OEMs) and some may also provide preventive maintenance and repair services for products made by other companies.