AdvaMed Statement On Medical Device User Fee Program

Janet Trunzo, executive vice president for technology and regulatory affairs at the Advanced Medical Technology Association (AdvaMed), issued the following statement regarding FDA's public meeting on the medical device user fee program:

"AdvaMed has long advocated for a strong and well-resourced FDA so it can perform its vital work of protecting and promoting the public health. The medical technology industry supported enactment of FDA's user fee program in 2002 (and its reauthorization in 2007) as a supplement to increased congressional appropriations in order to add stability and predictability to the review process and to encourage timely patient access to life-saving, life-enhancing medical technology.

"FDA's medical device program has benefitted from significant funding increases in recent years. Since 2007, FDA's device program has experienced a 37 percent budget increase and a 14 percent rise in staffing levels. The 2007 reauthorization for the user fee program doubled the industry's contribution to the agency's funding.

"At the same time, troubling trends have emerged in FDA's device review performance. For example, over the past few years the number of review cycles per 510(k) submission has increased by 36 percent while the time sponsors have had to spend in responding to FDA requests for additional data has nearly tripled. The agency also has indicated for the first time it will not meet one of its key user fee commitments for timely reviews of PMA applications submitted in FY 2008.

"We believe the agency needs to undertake a concerted review of its many activities and focus its time and resources on those areas that are likely to have the most significant impact in improving patient care. We urge FDA to carefully consider some of its recently released recommendations on the 510(k) process which will require enormous FDA resource commitments with little or no public health benefit.

"We look forward to working with FDA on developing performance commitments which are achievable and will make a significant difference in reaching our common goal of encouraging development and timely approval of safe and effective products which will benefit American patients."

Source: AdvaMed