In August 2010, working groups created by FDA's Center for Devices and Radiologic Health (CDRH) issued recommendations to change the regulatory structure for the U.S. medical device market. Intense controversy surrounds the issue, with safety concerns sounding off against the need to promote innovation. In January 2011, CDRH announced its plan to begin changing the 510(k) pathway, by which most devices are brought to market. Only the least controversial recommendations will be implemented now. Major structural change is deferred for more comment and consideration. In contrast to this cautious movement, CDRH spoke boldly in its Innovation Initiative, announced in February 2011 and designed to support cutting-edge technology that will significantly improve the options for seriously ill patients. The actual effects will depend on many factors, including available funds for implementation. Taken together, however, these plans would seem to indicate that industry concerns have been heard.

Controversial Changes Recommended

Most medical devices sold in the United States are brought to market through the 510(k) pathway, which allows new technology to be incorporated but requires devices to remain connected to those previously cleared by FDA. This process is caught in the crossfire. Consumer watchdog groups protest the danger of these devices, often cleared without having been tested in people first. On the other side, industry groups warn that the system has become so burdensome the U.S. will lose its global market dominance, along with countless jobs and breakthrough options that could save patients' lives.

The 510(k) process was established in 1976, when the Food, Drug and Cosmetic Act was amended to provide for FDA oversight of medical devices. With certain exceptions for low-risk devices, devices first introduced to market after May 28, 1976 were required to undergo an in-depth premarket approval process, unless the devices could be cleared for marketing through the 510(k) review. Devices eligible for this review must be substantially equivalent to devices that already were introduced to market before May 28, 1976. In broad terms, the process was meant to allow some evolution in indicated uses and technological characteristics, if device safety and effectiveness were not diminished.

This pathway is a critical one, traveled by the majority of medical devices sold in the United States. As technology advances, however, the process has become much more complex and increasingly uncertain.

In September 2009, CDRH established a task force to evaluate the use of science in regulatory decision making and a working group to consider the 510(k) process for clearing medical devices. Their reports, released in August 2010, suggested major changes to the framework for review. Although CDRH expressed its intent to protect both safety and innovation, many proposals were sweeping in nature and concerning to industry. Public comments reflected broad support for internal improvements at CDRH, but major objections were raised to adding burden or expense for the pathway to market. Leading industry voices were joined by a bipartisan group of legislators in emphasizing the need to maintain a well-functioning, efficient system for device clearance if the U.S. is to continue in its global leadership, keep jobs here and best protect patients.

As reflected in follow-up statements issued in January and February 2011, it appears these voices were heard. CDRH will enhance its talent and function, while supporting quicker paths to market for both new lower-risk devices and those offering breakthrough advances in treatment. As to the rest, CDRH will defer major change until after the Institute of Medicine (IOM) issues its own report this summer, and only after seeking additional public comment. Change is coming, but it may not be too disruptive, after all.

Cautiously Implementing Change

In January 2011 CDRH issued its Plan of Action, identifying 25 steps it will begin to implement. Changes that received strong support will be made without additional comment. CDRH will train its reviewers, to promote knowledge and consistency. A Science Center Council will be established and counsel from outside experts will be sought. New guidance documents will be issued and Notice to Industry letters will be sent, to clarify issues that have become confused and to make agency decisions more predictable and transparent.

A clarifying guidance will be issued to enhance use of the de novo classification process for low-risk new devices that cannot be cleared by reference to a predicate device. These devices begin with automatic placement into Class III, which would require a full Premarket Approval evaluation. The de novo classification process can move lower-risk devices out of Class III, allowing a much less burdensome and expensive path to market. CDRH seeks to support industry in making better use of this track.

CDRH will move more slowly in implementing more controversial changes. For example, proposed regulations will be issued to create a Unique Device Identification System, which would allow individual device tracking; public comments will be accepted. CDRH will analyze the use of multiple predicate devices as reference for clearance, make its results public and seek additional input. CDRH will hold a public meeting to discuss the proposed on-line labeling repository and will issue a proposed regulation for public comment with respect to the submission of device labeling to CDRH.

As for those changes that were most controversial, CDRH will wait. The IOM has been conducting its own evaluation on these issues; its report is expected this summer. Before further action, CDRH will hear IOM's thoughts about such issues as the greater use of rescission authority, greater authority to require postmarketing surveillance studies, and development of a new Class IIb for devices that typically will require clinical data. If CDRH decides to make changes after the IOM reports, it likely would issue specific proposed regulations, allowing additional space for public response.

Boldly Supporting Innovation?

In contrast to its more cautious movements to revise the 510(k) process, CDRH spoke boldly in its February 2011 Medical Device Innovation Initiative. The actual effects may be less than revolutionary, particularly if funding is not available for full implementation, but the tenor strongly supports technological advance. CDRH will host a public meeting on March 15, 2011 to discuss its plan.

One key feature is the Innovation Pathway, for breakthrough new technologies that will markedly improve the options available to treat or diagnose life-threatening or irreversibly debilitating diseases and conditions. For these devices, CDRH reviewers would be assigned from the outset, allowing them to shape the data generated during the development process and to learn the relevant science. Consequently, CDRH would be expected to make quicker decisions once the devices are submitted for approval. CDRH also will streamline the de novo classification process, to allow quicker and less costly pathways to market for new lower-risk devices that cannot be cleared by reference to existing predicates.

To strengthen our nation's regulatory science infrastructure, CDRH proposes to establish a certification process for third-party medical device test centers, create a publicly-available core curriculum for medical device development and better incorporate data generated in other countries. CDRH would enhance regulatory science through the continued direct research and participation of its own staff, while increasing its collaboration with private groups and other government agencies. Academic institutions also must be supported, to generate more talent and channel new people into medical device development. CDRH also wishes to steep its own scientists in new technology, so they will be prepared to move quickly when cutting-edge devices are submitted.

In his comments on the Innovation Initiative, CDRH Director Jeffrey Shuren observed that the United States can maintain its position as "the global leader in medical device development" only if we "strike the right balance between innovation and safety." This balance may be difficult to find, but the challenge has been engaged.