In an effort to promote innovation while protecting the population at large, the US Food and Drug Administration (FDA) has for several years been on a course to revise the existing regulatory pathway surrounding the 510(k) process for medical devices. One topic of concern focuses upon clinical data. Historically, this has plagued device manufacturers who risk submitting their 510(k) only to discover afterwards that clinical data will be required, or that perhaps even if they submitted clinical data, it was not enough. FDA’s efforts to review the current status of the program are intended, among other things, to result in changes that will provide prospective answers to device manufacturers regarding whether or not clinical data is required, and if so, to what extent. The purpose of this article is to establish the current status of the 510(k) process with regard to clinical data requirements, and then to begin a discussion regarding some considerations to be given when conducting a well-controlled clinical study, if indeed clinical data is required.
Current Status of 510(k) Clinical Data Requirements
The determination of whether or not a device clinical trial is required is largely based upon a risk stratification of the device, as illustrated in Exhibit 1 below. Minimal risk or Class I devices do not require a clinical trial, whereas some intermediate risk devices (Class II) and all substantial risk devices (Class III) do require a clinical trial.
Exhibit 1: Medical Device Risk Classification Chart