Improving Pre-Market Review for Medical Devices
In a non-rulemaking initiative, FDA and CMS intend to pilot a voluntary process for the parallel review of medical devices for marketing (FDA) and national coverage determinations (CMS) that will reduce the total combined time it takes for a medical device to be authorized for sale in the marketplace and then for payment under Medicare. This action will enable providers to know more quickly whether use of a particular device qualifies for reimbursement under Medicare, thereby potentially helping to facilitate patient access to the most up-to-date diagnosis and treatment procedures.
To further efforts to improve pre-market review, the FDA has assessed its process for premarket review of medical devices and established two significant initiatives to improve the agency’s medical device premarket review programs. First, FDA is implementing a Medical Device Innovation Initiative to support the development of innovative products by addressing some of the barriers that can impede a product’s timely progress to market. Complete information about the Medical Device Innovation Initiative can be found at http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHInnovation/default.htm.
Second, FDA is implementing the 510(k) Plan of Action, which calls for 25 actions during 2011 to improve the most common path to market for medical devices (the 510(k) pathway). These actions will make the 510(k) program a blueprint for smarter medical device oversight; one that drives innovation and brings important technologies to patients. Complete information about the 510(k) Plan of Action can be found at http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHReports/ucm239448.htm.