WASHINGTON (July 10, 2 p.m. ET) — President Barack Obama has signed into law a compromise bill that will double the user fees medical device manufacturers will pay over the next five years in exchange for faster government review and approval of products.
Under the industry-approved deal, medical device manufacturers will pay $595 million in user fees to the Food and Drug Administration over the next five years, compared with the $287 million they paid the previous five years.
In exchange for the higher fees, FDA has put together a five-year plan and agreed to have 90 percent of pre-market approval applications approved in 385 days, which would be a dramatic improvement from the current 38 percent rate. Typically, 40 PMAs are submitted annually.
Similarly, FDA is aiming to process 95 percent of the 4,000 501(k) applications it typically receives in a given year within 124 days, which would be an increase of 5 percentage points from its current rate.
“This legislation will help improve an already robust review process by giving FDA the additional tools and resources it needs to improve its timeliness and consistency," said Stephen Ubl, president and CEO of the Advanced Medical Technology Association.”
The bill was signed into law July 10.