This post was also written by Erin A. Janssen.
The FDA and representatives from the medical device industry reportedly reached an agreement in principle on proposed recommendations for the third reauthorization of a medical device user fee program, according to an announcement released February 1, 2012 on the FDA’s website. FDA claims the agreement “strikes a careful balance between what industry agreed to pay and what the FDA can accomplish with the amount of funding proposed. It would result in greater accountability, predictability and transparency through such improvements as a more structured pre-submission process and earlier interactions between FDA and applicants.” The recommendations would authorize the FDA to collect $595 million in user fees over five years, plus adjustments for inflation. Details of the agreement, such as the fee structure, are expected to be finalized soon.