- Medical devicemakers will pay the Food and Drug Administration nearly $1 billion in user fees from 2018 to 2022, under a proposed agreement announced this week.
- The deal, details of which will be released in coming weeks, represents a 68% increase over current device user fees.
- Congress must pass new user fee legislation before October 2017 when the current agreement expires.
The FDA and industry have been working for more than a year to hammer out a deal for the fourth authorization of the medical device user fee program. The last iteration, from 2012, set user fees at $595 million.
Jeffrey Shuren, director of the Center for Devices and Radiological Health, said the agreement “reflects the efforts the FDA has made to meet or exceed its performance goals and to help speed patient access to safe and effective medical devices.”
The funding will also boost efforts to collect real-world evidence on devices from registries, EHRs and other digital sources, he said.
In a joint release, the advanced Medical Technology Association, Medical Device Manufacturers Association and Medical Imaging & Technology Alliance praised the deal, saying it will allow the FDA to hire additional reviewers and conduct IT and infrastructure improvements.
The deal also sets lower time goals for reviewing 510(k) premarket notifications and premarket approval applications and would require the agency to provide feedback to companies at least five days before presubmission meetings are held, according to the groups. In addition, it enhances accountability by requiring two independent analyses of FDA’s handling of the review process —one at the outset of MDUFA IV and one at the end.
The FDA is expected to bundle all of its user fee programs — an agreement with prescription drugmakers was released last month — into a single legislative package, according to Politico Pulse. Negotiations with biologic and generic drug manufacturers are still underway.
Final recommendations on device user fees should be sent to Congress in January.