MITA Statement on Energy & Commerce Hearing

Rosslyn, Va. –  Given the significant impact the regulatory process has on medical device manufacturers’ ability to innovate and bring safe, effective diagnostic and radiation therapy to market, it is critical that regulators and industry continue to collaborate on improvements to regulatory processes, the Medical Imaging & Technology Alliance (MITA) said today.

“The 510(k) clearance program has a track record of protecting public health,” said Dave Fisher, Executive Director of the Medical Imaging & Technology Alliance.  “As manufacturers innovate diagnostic technologies, it’s important that the clearance process improve so that it can continue to spur innovation and create jobs.”

MITA has been heavily engaged in efforts to reform the Food & Drug Administration’s (FDA) 510(k) process, which is used to review and clear devices that are similar to those that have already been cleared by the Agency as safe and effective. In reforming the 510(k) process, MITA has encouraged efforts to improve transparency, predictability and timeliness.

A paper published Monday in the Archives of Internal Medicine on the 510(k) clearance process misleadingly claimed that a higher number of 510(k) medical devices are recalled than products cleared through the Pre-Market Approval (PMA) process. The authors failed, however, to put these numbers in context. There are more than 3,000 devices and diagnostics cleared through the 510(k) process every year compared to 20-40 products cleared through the PMA process.

Furthermore, the analysis looked at Class I recalls for high risk devices and used those numbers to question all 510(k) devices, unjustifiably recommending changes to the clearance process for all classes of devices, including devices that are low-risk, such as medical imaging technologies.

“The study uses a flawed analysis based on a simple count of the number of FDA recalls to draw inaccurate conclusions about the 510(k) process that would actually exacerbate the problem of timely patient access to innovative medical technologies.  MITA remains committed to working with the FDA to foster speed, transparency and predictability in the 510(k) process so that patients are never denied access to the latest treatment,” Fisher added.