Market access for Medical Devices and In Vitro Diagnostics in the US

Market access for medical devices and in vitro diagnostics (IVDs) in the US presents unique challenges and opportunities. Here are some key considerations:

In the USA, manufacturers must submit a 510(k) premarket notification to the Food and Drug Administration (FDA), demonstrating their device's substantial equivalence to a legally marketed predicate device for most Class I and certain Class II devices. Class III devices and certain high-risk Class II devices require premarket approval (PMA) from the FDA. Establishing a PMS system outlining data collection and analysis methodologies is also mandatory. 

Reimbursement for medical devices in the US is primarily overseen by the Centers for Medicare & Medicaid Services (CMS). Navigating this complex landscape, including Medicare coverage policies, coding, and payment rates, is essential for market access.