Medical device manufacturers will pay the FDA about $1 billion in user fees starting 2018 through 2022, according to HealthcareDIVE.
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.