Congress Proposes to Improve the Device Review Process by Amending the Least Burdensome and Conflicts of Interest Provisions in the Act

By Carmelina G. Allis

A billhas been introduced in the U.S. Senate, the “Medical Device Regulatory Improvement Act” (S. 1700)to amend the least burdensome and conflicts of interest provisions in Sections 513 and 712 of the Federal Food, Drug, and Cosmetic Act (the Act), respectively, in order to improve the premarket review process and foster innovation. These amendments would be a step in the right direction, but are unlikely to achieve the wholesale reform of CDRH that is needed.

The proposed amendments to the least burdensome provisions in Section 513 are intended to lessen the scientific burden imposed upon manufacturers during the PMA approval process. The amended provision would require the agency to find alternatives to reduce review times, and also consider alternative scientific approaches to evaluate the safety and effectiveness of a device for purposes of approval. For example, the agency would be required to accept, whenever practicable, alternatives to randomized, controlled clinical trials in support of PMA approval.

It would also require FDA to consider alternative approaches during the review of both 510(k)s and PMAs in order to reduce the “time, effort, and cost of reaching proper resolution” of scientific/regulatory issues. If the term “cost” refers to monetary cost to the manufacturer, and this proposed bill becomes law, it would be interesting to see how FDA handles this issue. CDRH does not consider a manufacturer’s product development costs during the device review process (it is not authorized to do so by the Act or its implementing regulations). And, thus, countless agency’s requests for data are burdensome and costly, and the agency generally overlooks a manufacturer’s request for a more reasonable approach. This proposed amendment looks promising in that it would require CDRH to take into consideration alternatives in its quest for additional data and weigh in cost before requiring a manufacturer to pursue a particular path.

The proposed bill would also require that the agency not request or accept information that is not relevant to a 510(k) substantial equivalence (SE) determination. Because this proposed amendment appears to only clarify the scope of the least burdensome provisions, rather than add new meaning to them, we doubt that this amendment will have much practical impact on the 510(k) review process. FDA’s 510(k) correspondence has carried the “least burdensome” boilerplate since 1997 but it never seems to pose much of a constraint for the agency.

The proposed bill also includes an amendment to Section 712 of the FDC Act, which would require the agency to enter into a contract with an entity experienced in evaluating the management and operating structure of large organizations. The entity would review the management and regulatory processes at CDRH “to ensure any actions carried out by such Center take into consideration the potential impacts on innovation with respect to medical devices and other products regulated by such Center.” The entity would be required to submit a report to Congress on its findings and recommendations within a year after the effective date of the contract.

This management consulting review provision might be helpful in bringing about necessary reform at CDRH. Still, this entity would not be the first one to criticize the management and regulatory processes at CDRH. In fact, several GAO reports and the most recent IOM report on the 510(k) process have done just that, but there has been no improvement within the Center. Given this track record, we remain skeptical that this particular provision would improve the status quo in CDRH.