Here are five takeaways:
1. This proposed agreement reflects a 68 percent spike over current device user fees.
2. The funding will enhance the industry’s ability to gather real-world evidence on devices, electronic health records and various digital sources.
3. The Medical Technology Association, Medical Device Manufacturers Association and Medical Imaging & Technology Alliance back the deal, commenting it enables the FDA to hire more reviewers and carry out IT and infrastructure enhancements.
4. The proposed agreement also cuts the time for reviewing 510(k) premarket notifications and approval applications.
5. Congress has until October 2017 to pass the proposed user fee agreement.
More articles on devices:
SI-BONE’s iFuse continues to gain steam — 6 observations from trial yielding 2-year results
Medtronic, Stryker among top spinal fixation market players— 3 things to note
Medical device fees to FDA will be nearly $1B, but review process to improve: 5 key notes
At the Becker's 23rd Annual Spine, Orthopedic and Pain Management-Driven ASC + The Future of Spine Conference, taking place June 11-13 in Chicago, spine surgeons, orthopedic leaders and ASC executives will come together to explore minimally invasive techniques, ASC growth strategies and innovations shaping the future of outpatient spine care. Apply for complimentary registration now.
