The body of evidence gathered from the committee’s evaluations influenced its deliberations. The conclusions and recommendations presented in this chapter are the results of the committee’s deliberations.
To assess whether the 510(k) clearance process is protecting the public’s health by providing reasonable assurance that marketed Class II medical devices are safe and effective, the committee explored two avenues. The committee studied 510(k)-related legislation to determine whether the statute governing the 510(k) program provides for the FDA’s goals for this program (described below). The committee also evaluated available information on the safety and effectiveness of marketed medical devices.
The Regulatory Framework of the 510(k) Program
As outlined in Chapters 2 and 4, the committee found a substantial disconnect among the committee’s statement of task, the Center for Devices and Radiological Health (CDRH) statement of the goals of the 510(k) clearance process, and the FDA’s statute governing the 510(k) clearance process. The committee’s statement of task reads:
The current 510(k) process reflects the statutory framework and the U.S. Food and Drug Administration’s (FDA) implementation of the framework; it is intended to meet two important goals: 1) make available to consumers devices that are safe and effective, and 2) promote innovation in the medical device industry.
Similar language describing the goals of the 510(k) process are included in the CDRH Preliminary Internal Evaluations, Volume 1—510(k) Working Group Preliminary Report and Recommendations (FDA, 2010a, 128), which states that
the aim of the 510(k) program is two-fold: (1) to assure, through a quality review process, that marketed devices, subject to general and applicable special controls, provide a reasonable assurance of safety and effectiveness; and (2) to foster innovation.
However laudable those goals may be, they are not the purposes that Congress embedded in the 510(k) program (Findings 2-2 and 2-5).
In practice, the assessment of substantial equivalence generally does not require evidence of safety or effectiveness of a device. Unlike the premarket approval (PMA) process, by law the 510(k) process, with some exceptions