Special guidance for device studies How do I determine whether Medicare has approved a category A or B device study under an investigational device exemption (IDE)?You can visit the CMS website for Approved IDE Devices , and enter the name of the device in the search area. You will then be able to view the study that is CMS approved for the device in question. The study information will include the NCT#, IDE#, CMS approval date, and device category. The NCT # will enable you to search the clinicaltrials.gov website for additional information about the device study (e.g. study site locations and contacts, recruiting/not recruiting, study type, study phase, primary purpose, etc.)6 | |
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