You are here

Mark E. Brager
June 11, 2014

AdvaMed Commends BAH Report on Device Review Process

WASHINGTON, D.C. – Janet Trunzo, senior executive vice president, technology and regulatory affairs, for the Advanced Medical Technology Association (AdvaMed), issued the following statement on today’s release of reports from Booz Allen Hamilton (BAH) and FDA assessing the agency’s medical device review process:

“While AdvaMed is still reviewing the details of the BAH report, we are pleased that the report’s recommendations support the association’s long-held priorities on the need to improve the consistency in decision-making throughout FDA’s review process and to enhance reviewer training and management oversight within the agency’s device center.

“Of the seven new recommendations in BAH’s report, AdvaMed is particularly supportive of the proposal to analyze the root-cause of withdrawn submissions and to develop mechanisms to reduce their occurrence. While we have seen some improvement in total review times in recent years, the percentage of withdrawn submissions remains unacceptably high.

“In addition, we look forward to progress on BAH’s recommendation to optimize the device center’s refuse-to-accept (RTA) process. An increasing number of 510(k) submissions are being denied by the agency under this process, and we believe it could benefit from more consistent implementation by FDA as well as additional information to sponsors on the administrative requirements for 510(k)s.

“We commend BAH for the comprehensive nature of their recommendations and for taking into account the feedback and concerns of the medical technology industry in developing their report.

“Regarding FDA’s report on the four priority recommendations issued by BAH in December 2013, we are encouraged by the agency’s commitment to implement the four recommendations. We look forward to learning further of FDA’s implementation plans and of monitoring the agency’s progress in meeting these important goals.”


# # #

AdvaMed member companies produce the medical devices, diagnostic products and health information systems that are transforming health care through earlier disease detection, less invasive procedures and more effective treatments. AdvaMed members range from the largest to the smallest medical technology innovators and companies.