Is the pathway to quicker medical device regulatory approval or clearance to be found through the establishment of higher fees on the part of the Food and Drug Administration? It would seem so, given that the FDA has recently announced a new program that will double the amount of the user fees currently paid by the biggest players in the medical device industry. The new five-year medical device user fee deal, which is still awaiting Congressional approval, would seek $595 million from medical device manufacturers – a jump from the previous $287 million called for by the last five-year agreement. Another key component of the agreement is the requirement that the FDA meet with device companies through the process to address concerns and set goals for reducing review times.
Where will this money go? The FDA has stated that the additional funds kicked in by medical device manufacturers will be earmarked for the hiring of new staff to expedite the approval of products submitted to the agency. In total, the FDA plans to add 200 workers to its payroll by the time the five-year deal expires. The move is seen as a crucial one by industry executives frustrated with the persistent increase in medical device approval wait times over the course of the past three years. This is a bureaucratic issue that has both government officials and medical device experts cautioning that the United States is at risk of falling behind the global market in terms of innovation. Several other programs, including a streamlining of the 510(k) process, have also been launched in order to address the same problem.
Adding regulatory experts to the FDA’s roster is no guarantee that medical device clearance/approval times will begin to contract to a more competitive level, but it is certainly a step in the right direction. Previous criticisms of the Agency’s handling of the 510(k) process included issues with employee turnover and the inability of personnel to distinguish between critical and ‘nice to know’ information supplied with each device submission. Increasing FDA funding via industry contributions may be necessary to accelerate the commercialization of new medical devices, but industry, especially smaller, emerging device innovators, will certainly expect CDRH reviewers to do their part to speed the pace of medical device innovation without sacrificing public safety.
adapted and republished from Aptiv Solutions BlogSUBSCRIBE TO OUR MONTHLY NEWSLETTER>>