Fda And Obtain Clearance Of Their Safety And Effectiveness For Enter The Market

1096 WordsDec 22, 20165 Pages
In order to be legally marketed in the US, many medical devices must be reviewed by the FDA and obtain clearance of their safety and effectiveness to enter the market. The regulations can affect the cost, quality, and availability of medical devices. Pre-Market Approval and 510(k) Clearance There are two FDA processes for different medical devices: Premarket Notification 510(k), and Premarket Approval (PMA). A PMA is required of new Class III high-risk devices. Companies need to submit evidence that provides reasonable assurance that the device is safe and effective. The PMA can take more than 450 days and the clinical data required can cost millions to collect. Most Class I and Class II devices (low- to moderate-risk devices) only need to receive 510(k) clearance before being marketed. The companies only need to demonstrate that the device is “substantially equivalent” to a device already on the market (a predicate device) that does not require a PMA. The 510(k) clearance tends to take around 200 days and costs much less than PMA. Access to the US market FDA approval enables medical device companies to access the US market, 43% of the global medical device market. According to National Health Expenditures in 2012, the $140 billion medical device market has grown at a rate of 6% annually in the US. Coverage under Medicare Getting FDA-approval is the first step to enter the healthcare system. Centers for Medicare & Medicaid Services requires devices to be FDA-approved

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