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# FDA, Device Industry Agree to $400 Million Jump in User Fees
- URL: https://www.fdaweb.com/fda-device-industry-agree-to-400-million-jump-in-user-fees/
- Published: 2016-08-23T12:00:00.000Z
- Updated: 2026-09-14T21:26:22.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5136580

FDA and the medical device industry have reached an agreement in principle on the next round of user fees that will see fees skyrocket by about $400 million (67%) over the next five years beginning 10/1/2017\. This is the fourth reauthorization of the [*medical device user fee program*](http://www.fda.gov/ForIndustry/UserFees/MedicalDeviceUserFee/default.htm?ref=fdaweb.com), and under the draft agreement, the agency would be authorized to collect $999.5 million in user fees plus adjustments for inflation each year until 2022\. “This funding would provide critical resources to the FDA medical device review program,” and [agency release](http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/UCM517609.htm?ref=fdaweb.com) says. “This funding will also improve the collection of real-world evidence from different sources across the medical device lifecycle, such as registries, electronic health records, and other digital sources.” Details will be published for public comment in the coming weeks, FDA says, adding that the final recommendations are scheduled to be delivered to Congress in 1/2017.

Advanced Medical Technology Association says it supports the proposed agreement. The group cites key performance goals that include:

- Significant improvements for total review time goals, which will lower the total time goal for 510(k)s and PMAs to historical norms.
- Greater accountability through two independent analyses of FDA’s management of the review process – one at the beginning and one at the end of the MDUFA IV timeline – and implementation by the agency of a quality system management approach to the device review process. FDA’s quarterly and annual reporting requirements have been enhanced as well.
- Further process enhancementsto increase the consistency and timeliness of the review process. These include FDA commitments to provide feedback to companies at least five days prior to a pre-submission meeting; a requirement to document the rationale for issuing a deficiency letter; implementation of a standards conformity assessment program; and a pilot to assess the effectiveness of real-world evidence to support premarket activities.