Medical device makers have tentatively agreed to have FDA review fees doubled starting this year. The current five year agreement, set to expire on September 30, 2012, is set at $287 million. If the new deal is signed off by Congress, the FDA is set to receive $595 million in user-fees over the next five years. As a result, there will be reductions in total review times, a greater number of pre-market and 510(k) approvals, and more communication with companies during the review process. The agreement will also require FDA reviewers to meet with the applicants halfway through the process to make sure any concerns are addressed and that goals are being met.
There has been criticism from the industry in the past few years on slow approval times, and last minute safety data requests that can cost companies a lot of money. This can hinder innovation because the process has become so cumbersome and unexpected costs make it unpredictable. Even with this proposed increase, medical device companies will still be paying a smaller portion of the FDA’s review budget. Drug companies currently pay about 60%, while device companies will be paying about 35% of the budget after the increase.
If you would like to learn more about how to plan for biocompatibility testing, and for detailed information on ISO and FDA regulations for medical devices, download the 26-page booklet on Assessing Biocompatibility.