Last week the House voted to pass the FDA user fee re-authorization act, which allows for the collection of fees from drug and device manufacturers to support the FDA in its review activities. This latest iteration of the legislation would update the target base user fees collected from devicemakers to $130.2 million in FY2017, $183.3 million in FY2018 and reaching $213.7 million in FY2022.
An infographic produced by AdvaMed, the medical device lobby which is supportive of the re-authorization act, summarized some of the commitments the FDA is offering under the renewed agreement. They include shortening review times for 510(k) applications and PMAs, incorporating novel study designs and attributes, such as the use of real-world data and patient-focused endpoints, into submissions and providing more specifics in deficiency letters, so that companies may better understand the issue and how to remedy it.
Now that the bill has passed the House, the next step is the Senate to vote on their version of the bill. Congress has until September 30 to finalize the legislation, at which point the prior user fee agreement expires.