FDA Guidance IDE Device Medicare Coverage

The US FDA issued a draft guidance entitled: “FDA Categorization of Investigational Device Exemption (IDE) Devices to Assist the Centers for Medicare and Medicaid Services (CMS) with Coverage Decisions”. This draft defines criteria for determination of Class A or B. This is very important for companies where Medicare/Medicaide reimbursement is a factor. The key is wheter FDA considers a device expirmental (where safety and effectiveness is unknown per 42 CFR 405.201(b)) or investigational (where initial questions of safety and effectiveness have been resolved per 42 CFR 405.201(b).).