As previously reported here, FDA and medical device industry reached a tentative user fee agreement earlier this month. The tentative agreement calls for $595 million to be paid to FDA in exchange for a number of performance goals and other measures meant to provide a faster, more streamlined review process. The proposed agreement has not yet been submitted to Congress (FDA expects to submit the proposal by mid-March.), but that did not stop the House Energy and Commerce Health Subcommittee from discussing the proposal at its February 15 device user fee reauthorization hearing.
A central concern with a number of the representatives was the magnitude of the increase in user fees. The proposed agreement calls for the medical device user fees to roughly double over the life of the five-year agreement. Jeffrey E. Shuren, M.D., J.D., Director of FDA's Center for Devices and Radiological Health ("CDRH"), defended the increased fees. According to Shuren, CDRH is in desperate need of additional funding to increase its review staff and improve the review process. Shuren also stressed that the increased user fees for small firms would not increase as significantly as the overall user fees. For example, a 510(k) submission fee for a small firm (those having annual revenues of $100 million or less) would start at $2000 in 2012 and top out at $2600 in 2017. A summary of some of the other fees include:
- Roughly $220,000 for a Pre-Market Application ("PMA") or Biologics License Application ("BLA") in 2012; small firms would pay roughly $55,000. These figures rise to roughly $268,000 and $67,000, respectively, in 2017.
- Larger firms would pay around $4,000 for a 510(k) submission in 2012 and around $5,400 in 2017.
- In 2012, the device registration fee (a fee paid by all registered device makers and reprocessors) will be a little over $2,000, but it will grow to almost $4,000 by 2017.