By Jeffrey K. Shapiro –
Ten years ago, Congress commanded FDA to ease the burden of Medical Device Reporting (MDR) for most class I and class II devices. Four years ago, we blogged about it here. FDA still has not gotten it done.
Specifically, Section 227 of the Food and Drug Administration Amendments Act of 2007 FDAAA) amended Section 519 of the Federal Food, Drug, and Cosmetic Act (FDCA), directing that FDA “establish” summary quarterly reporting of malfunction MDRs for most class I and class II devices. It is not clear whether Congress expected FDA to establish the new requirements by amending the MDR regulation or by issuing guidance; the language seems open to either possibility.
This congressionally ordered change to MDR reporting is sensible. One of the most difficult aspects of MDR reporting is making a probabilistic determination as to whether a malfunction that did not cause a serious injury would be “likely” to do so if it were to recur. We blogged about some aspects of the problem here.
It is astonishing that FDA has flouted the law for ten years, and almost nothing is even said publicly about it. In such a situation, one is tempted to give up hope that change will ever come.
But new hope has arrived! On January 30, 2017, President Trump issued an Executive Order (EO) titled, “Reducing Regulation and Controlling Regulatory Costs.” As described in more detail in an earlier blog post, this EO puts the entire Executive Branch on a strict regulatory diet. Every new regulation must be accompanied by removal of two old regulations, and “regulation” includes significant guidance.
That is where the change to the MDR reporting comes in. Although FDA would technically be issuing a new regulation (or guidance), in doing so it would lift an existing burden rather than impose a new one. Therefore, FDA should easily be able to persuade OMB that issuing this change is deregulatory and gives FDA a credit toward new regulations.
Perhaps with this brand new incentive dangling in front of it, FDA will at last amend the MDR regulations as required by law. Hope springs eternal!