In an interview with the Wall Street Journal last week, FDA Commissioner Margaret Hamburg spoke to some of the ongoing concerns about the regulatory process for medical devices, saying the agency would take a "hard look" at the CDRH.
The Journal stays that Hamburg has been in touch with former FDA Commissioner David Kessler regarding concerns about the approvals process. He has called the device group "dysfunctional" and "in meltdown." Hamburg is clearly looking to address allegations that the industry has too much influence over product approvals, and she also noted that recalls and relabeling efforts should happen more quickly.
This announcement follows an editorial in the NEJM, penned by Hamburg and Deputy Commissioner Joshua Sharfstein, that described the new administration's ambitions for the agency as an advocate for the public health. The review of the CDRH is clearly another piece of that vision, with the Journal describing the NEJM article as "[throwing] down a gauntlet."
Medical device lobbies, including the Advanced Medical Technology Association, have raised concerns that complicating the 510(k) clearance process may limit patient access to new technologies. Additionally, AdvaMed argued in a statement that the 510(k) process is sufficiently rigorous, and that it is "a system that has served the public effectively for over 30 years." AdvaMed emphasized that 510(k) applications require FDA review of specifications and performance testing, and in some cases, clinical data. Once a product is on the market, the FDA enforces manufacturing controls and oversees adverse events reporting to ensure that the devices continue to be safe and effective.
