IOM Completes Independent Review of the 510(k) Process
BY SANDER DUNCAN, APRIL 5, 2011
The Institute of Medicine (IOM) completed its review of the FDA’s 510(k) clearance protocol last week. The report has been widely anticipated since 2009, when the incoming FDA administration ordered an independent review of the 510(k) process to complement its own internal study.
Though the text of the review is not yet available, the study is already generating controversy. In particular, industry stakeholders are voicing concern over the lack of private-sector medtech representation on the IOM panel conducting the review. Some reports note that the panel’s two industry representatives come not from the medtech world but from the healthcare insurance industry. To address these concerns, the IOM has tapped Medtronic veteran Dale Wahlstrom to provide guidance on a list of people to add to the panel.
The IOM study is the external component of a comprehensive review of the FDA’s most common approval pathway for medical devices. In January, following a year-long internal study, the FDA proposed 25 changes that address transparency and efficiency hang-ups in the approval process. While the FDA’s study addressed more minor tweaks to the 510(k) process, the IOM report is expected to make recommendations on broader, more controversial changes. These topics include establishing internal conflict resolution procedures, and the creation of a “Class IIb” device classification.
CDRH director Dr. Jeff Shuren said that the FDA will seriously consider any significant changes suggested in the IOM’s report, which is due later this summer.
