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The US FDA issued a draft guidance entitled: “FDA Categorization of Investigational Device Exemption (IDE) Devices to Assist the Centers for Medicare and Medicaid Services (CMS) with Coverage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).).

Upcoming Training

QSS Software Validation
Planned Instructors:  Brian Pate, John Murray
Location: Boston, MA, USA
Dates:  June 2-4, 2020
Registration Link

Receive $300 discount with Premium-Individual subscription purchase (or $333 per person for Premium-Company subscription)! 

Multi-Student Discounts as well!

Email training@softwarecpr.com
to receive discount

Corporate Office

15148 Springview St
Tampa, FL 33624
Partners located in the US (CA, FL, MA, MN) and Italy.