CDRH’s New Post-Market Paradigm: Why the Public Should Be Worried

Medtech Insight

Bradley Merrill Thompson, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, authored an article in Medtech Insight, titled “CDRH’s New Post-Market Paradigm: Why the Public Should Be Worried.”

Following is an excerpt (see below to download the full version in PDF format):

US FDA is working on several projects intended to improve the flow of real world evidence to its Center for Devices and Radiological Health. That is the core goal of the nascent National Evaluation System for health Technology (NEST). It is also a major component of the pilot-stage Digital Health Software Precertification Program. In establishing these programs, CDRH wants to receive more data that may reveal potential post-market safety signals. While these programs raise a range of important policy issues, one of the most pressing issues is what CDRH will choose to do with this new data.

According to the device center’s recently proposed Medical Device Safety Action Plan, CDRH wants to use the data to direct manufacturers to engage in post-market corrective actions, whether recalls, notification, or some other step. If the past is prologue, even though FDA lacks the legal authority to simply order the corrective actions without following some sort of due process. (See sidebar, “FDA’s Present Authority To Require Post-Market Corrective Action.”) CDRH will direct manufacturers to engage in corrective actions under the threat that, if the manufacturer doesn’t cooperate, CDRH will conduct its own marketplace notification.

If that was all CDRH had planned, it would be reason enough for concern. But CDRH seems to want more than just the power of coercion. In the Medical Device Safety Action Plan, as well as other recently proposed new programs, the center is signaling that it wants dramatic changes in its authority to decide how best to respond to perceived post-market safety signals, and those changes carry with them potentially significant negative consequences for the public health. This article analyzes what CDRH wants to change and discusses the policy implications.