Who is required to file mandatory reports of device-related adverse events?
A. An ambulatory surgical facility is a distinct entity whose primary purpose is to furnish same day outpatient surgical services to patients. A facility that offers LASIK as one of its ophthalmic surgical procedures may also provide non-ophthalmic surgical services. Consider all surgical services provided by a facility when determining whether a facility meets the MDR definition of an ambulatory surgical facility and is therefore subject to the user facility obligations under MDR. More information about mandatory reporting can be found at http://www.fda.gov/MedicalDevices/ Safety/ReportaProblem/default.
