On Nov. 28, the ACC submitted comments to the U.S. Food and Drug Administration (FDA) on the draft Medical Device User Fee Amendments (MDUFA) IV agreement released in late Oct.  First instituted in 2002, MDUFA requires medical device companies to pay fees to the FDA that, in turn, help the Agency decrease the amount of time it takes to review applications for new medical devices and fund additional process improvements that benefit patients. The agreement is negotiated by the FDA and industry, with input from patient and consumer stakeholder groups, and will be sent to Congress for approval in early Jan.

The College's latest comments commend the FDA for its clear efforts to integrate its concerns, as the agreement addressed ACC's main priorities including a stable, predictable approval pathway, utilization of stakeholder expertise, and development of a medical device evaluation system. Ralph G. Brindis, MD, MPH, MACC, represented the College at a public stakeholder meeting held Nov. 2 to discuss the agreement and offer stakeholder input.

Read the full comment letter.

Keywords: Device Approval, Fees and Charges, Fees, Medical, Financial Management, United States Food and Drug Administration

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