The FDA and representatives from the medical device industry have agreed to set the user fees at $595 million over five years, plus adjustments for inflation, according to an FDA news release.
The new user fees are double the previous amount of $287 million. In exchange for the fees, the FDA has agreed to overall performance goals such as reviewing a certain percentage of applications within a specified time frame and hiring more than 200 full-time workers by the end of the five-year program. Details of the agreement, such as the fee structure, should be finalized soon.
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The new user fees are double the previous amount of $287 million. In exchange for the fees, the FDA has agreed to overall performance goals such as reviewing a certain percentage of applications within a specified time frame and hiring more than 200 full-time workers by the end of the five-year program. Details of the agreement, such as the fee structure, should be finalized soon.
Related Articles on Medical Devices:
Congress to Consider Bill to Repeal Medical Device Tax
FDA Announces 2012 Medical Device Strategic Priorities
FDA Misses Deadline in Conflict with Medical Device Makers Over Approval Process