Class III devices do not warrant annual payment update
The Government Accountability Office is recommending that Congress consider establishing a uniform payment update to the DME fee schedule for 2008 for class II and III DME devices. GAO conducted a study and found that manufacturers of class III devices, with limited exceptions, have higher premarketing costs than manufacturers of class II devices that are similar to class III devices.
Class III devices do not warrant annual payment update
The Government Accountability Office is recommending that Congress consider establishing a uniform payment update to the DME fee schedule for 2008 for class II and III DME devices. GAO conducted a study and found that manufacturers of class III devices, with limited exceptions, have higher premarketing costs than manufacturers of class II devices that are similar to class III devices. Premarketing costs consist of FDA user fees and research and development costs.
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FDA’s Recent Exemptions: What Do They Mean as We Finalize DSCSA Implementation?
October 31st 2024Kala Shankle, Vice President of Regulatory Affairs with the Healthcare Distribution Alliance, and Ilisa Bernstein, President of Bernstein Rx Solutions, LLC, discussed recent developments regarding the Drug Supply Chain Security Act.
