Author: monroemacandie

FDA Statement on Medical Device User Fee Amendments (MDUFA)

WEBWIRE – Wednesday, March 23, 2022 The FDA and representatives from the medical device industry have reached an agreement on proposed recommendations for the fifth reauthorization of the medical device user fee program. Under the new agreement, the FDA would be authorized to collect at least $1.78 billion in user fees over five years, plus additional funding, for a total of up to $1.9 billion to further improve performance if specified goals are met. This funding would provide critical resources to the FDA medical device review program. The proposed recommendations have been posted on our website and will be published in ... Read more