The Advanced Medical Technology Association (AdvaMed) released a statement Sept. 16—the date of an FDA public meeting on the Institute of Medicine’s (IOM's) 510(k) report—detailing its opposition to the IOM's findings. The statement from Janet Trunzo, executive vice president for technology and regulatory affairs for AdvaMed, followed another critical review of the report issued in July from AdvaMed President and CEO Stephen J. Ubl.
“AdvaMed welcomes the opportunity provided by FDA to comment on the recent IOM 510(k) report. While we commend the IOM committee’s efforts and believe its report contains a number of valuable observations and recommendations, we strongly disagree with its central recommendation to abandon the current 510(k) program and to replace it at some unknown date with an untried, unproven, and unspecified new legal structure,” Trunzo said. “The 510(k) review process works well and has a remarkable safety record. The IOM committee itself acknowledges that there is no evidence that the 510(k) process is failing to assure safety and effectiveness.”
Trunzo said the FDA must evaluate whether the safety and effectiveness of a 510(k) device is comparable to that of a predicate device, and pointed out that manufacturers submit scientific evidence to demonstrate substantial equivalence to lawful predicates.
“Medical technology companies and FDA agree the device center faces challenges: escalating review times, lack of clarity in data requirements and inconsistency in information requests,” said Trunzo. “If properly executed, FDA’s comprehensive 510(k) action plan could address many of these issues by issuing additional device-specific guidance documents, enhancing reviewer training and better leveraging external scientific experts.”
AdvaMed also expressed unequivocal support of some IOM recommendations, including:
- Streamlining the de novo process and clarifying the program’s evidentiary expectations.
- Instituting an internal quality assurance program within FDA’s device center to assess the quality, consistency and effectiveness of the 510(k) program.
- Expeditiously issuing classification regulations for those pre-amendment Class III device types currently reviewed through the 510(k) process.