FDA Categorization of Investigational Device Exemption (IDE) Devices to Assist the Centers for Medicare and Medicaid Services (CMS) with Coverage Decisions
- Docket Number:
- Issued by:
Guidance Issuing OfficeCenter for Devices and Radiological Health
This guidance modifies the Food and Drug Administration’s (FDA’s or the Agency’s) current policy on categorizing investigational device exemption (IDE) devices, which assists the Centers for Medicare & Medicaid Services (CMS) in determining whether or not an IDE device should be covered (reimbursed) by CMS.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2016-D-1159.