The Advanced Medical Technology Association (AdvaMed) criticized a new report by the consumer advocacy group Public Citizen that took issue with the government's expedited review for certain medical devices.
The report raises concerns with the premarket notification, or 510(k), process, under which device makers can secure expedited approval if they can show that their device is "substantially equivalent" to a device that's already on the market.
"Public Citizen’s statement that there is a lower approval standard for devices than for drugs demonstrates their lack of understanding of the medical device review process and the fundamental differences between medical devices and drugs, differences that Congress recognized when it first crafted FDA’s medical device law over 30 years ago to address the unique characteristics of the industry," said senior executive vice president David Nexon.
"The breadth and diversity of medical technology, ranging from low-risk products like tongue depressors to highly complex implantable devices such as pacemakers and neurostimulators, and the volume of product applications to FDA — approximately 3,600 per year — is also quite different from the more homogenous model for the drug industry. Such a diverse field of life-saving, life-enhancing technologies requires a review process that can be tailored to the specific device being reviewed and its relative risk and benefit. A ‘one-size-fits all’ approach to medical device reviews would be a tremendous disservice to patients."