Addressing concerns on changes to the 510(k) process
On Dec. 17, 2010, William M. Mihalko, MD, PhD, representing the AAOS and the Alliance of Specialty Medicine, along with other surgeon members and society representatives had a unique opportunity to meet with Jeffrey Shuren, MD, JD, director of the Center for Devices and Radiological Health (CDRH) in the U.S. Food and Drug Administration (FDA).
Each year, 90 percent or more of medical devices reach the market through the FDA’s 510(k) process (Fig. 1). Dr. Mihalko, who chairs the AAOS Biomedical Engineering Committee, and other surgeons voiced concerns about the changes proposed in the CDRH’s internal review of the 510(k) process. The FDA report includes more than 70 recommendations to revise the 510(k) process, many of which raised questions among the physicians in attendance.
As reported in the October 2010 edition of AAOS Now, the FDA convened an internal working group in September 2009 to evaluate the 510(k) program and suggest changes to improve consistency, with an emphasis on actions that could be taken within the Agency’s existing statutory authority. At the same time, the FDA commissioned the Institute of Medicine (IOM) to complete an independent study of the program. Although the FDA has issued its internal recommendations, the IOM 510(k) panel is not expected to present its recommendations until the third quarter of 2011.
Dr. Shuren assured the group that CDRH will be moving forward “fairly quickly” toward identifying those recommendations that will be implemented and those that will be referred to the IOM for their consideration. Some of the IOM recommendations are expected to require legislative changes.
The following issues were among those addressed during the meeting.
One of the recommendations focused on the possibility of providing the FDA with “express authority to consider an off-label use … when determining the ‘intended use’ of a device under review through the 510(k) process.”
Dr. Shuren clarified that the FDA is not attempting to regulate the off-label use of products. The CDRH recommendation intends to address the rare occurrence of a manufacturer planning to market a product in a manner intentionally inconsistent with and/or not included in the application. This is not viewed as a high priority recommendation by the FDA.
Intended use/indications for use
The FDA working group recommended that CDRH consolidate the concepts of “indication for use” and “intended use” into the single term “intended use.” The meeting made clear that the FDA does not intend to constrain the practice of medicine with this recommendation. Rather, it is intended to increase internal consistency in the application of these terms within the agency, which has used them interchangeably in some documents.
The FDA acknowledged the concern over this recommendation and the Alliance surgeons asked federal officials to be cognizant of the unintended consequences of implementing this recommendation, particularly the way in which payers might interpret the language.
Under limited circumstances, the FDA may compel a manufacturer to engage in postmarket surveillance of a product as a condition of approval; this authority is primarily limited to premarket applications (PMAs) and pediatric products. In some cases, there are unanswered questions and the FDA needs additional long-term data to be able to clear a product.
CDRH does not believe that it has enough authority to mandate this type of study, and one of the workgroup recommendations was to seek such authority. Most postmarket studies are restricted to 3 years (except for pediatric products) and apply to implantable life-sustaining or life-supporting products. CDRH views this as a way to avoid upclassification for products with lingering unanswered questions.
Multiple and split predicates
Predicates are devices that have been previously tested and approved, and which equivalent devices may use as a reference for approval. The recommendations on this issue focus on additional staff training and guidance development.
During the meeting, the FDA pointed out that it supports the use of multiple predicates and seeks to achieve internal consistency and compliance with existing law with respect to split predicates. The recommendation to disallow the use of split predicates addresses the infrequent instances when one predicate is cited in the application to support the intended use of the product but an entirely different predicate is used to support the substantial equivalence claims for technological characteristics.
Notice to industry
The FDA believes it needs to be clearer in communicating current thinking when science changes, both in general and regarding specific examples. Because guidance documents take a long time to produce, one workgroup recommendation was to use “Notice to Industry” letters as a way to communicate current thinking in light of new science in a much shorter time frame (weeks versus years).
Labeling and 510(k) database
Under the current process, the FDA does not see the final labeling for 510(k) applications, just the draft language that is submitted. To address this issue, the workgroup recommended that manufacturers be required to submit labeling each year when listing with the FDA. A publicly available, searchable database would provide easy access to this information.
To improve both the quality and consistency of reviewers and their decisions, the workgroup recommended the establishment of a Science Council. The Science Council establishes a network of experts, including those with conflicts, who could act as a sounding board for the Agency.
The FDA will develop standard operating procedures for the Science Council, explaining how it will use experts and the information gathered. This will differ from the Science Board, which is an advisory panel governed by the Federal Advisory Committee rules and various aspects of the Sunshine Act.
Class IIb devices
The workgroup recommendation to establish “class IIb” devices that would require submission of clinical information, manufacturing information, or additional postmarket evaluation is intended as a way to “capture the practice of the FDA, not to change it” and was viewed as a concession to industry. The recommendation was based on initial suggestions from industry and was viewed favorably by Europeans who found it to be closer to their regulatory model and thus affording more opportunities for global harmonization.
The recommendation generated significant negative feedback, however, which surprised the FDA. It will undergo further scrutiny, likely with the IOM panel.
The FDA will release a summary of the public commentary received on the 510(k) and new science reports when decisions regarding implementation and referral of recommendations are released.
The meeting initiated an open dialogue that will facilitate feedback to the Agency as its recommendations are implemented. Although Dr. Shuren’s reassurances regarding the intent of many of the recommendations were well-received, it remains to be seen how the changes will be applied as devices navigate the revised pathway to market. The current CDRH leadership may be committed to the approaches outlined in the meeting but changes in personnel, such as the recent departure of FDA Principal Deputy Commissioner Joshua Sharfstein, MD, could result in different interpretations of the regulations in the future.
AAOS will continue to interact with the FDA, the IOM, and members of Congress as the recommendations to amend the 510(k) process become public, and will keep AAOS members informed about the impact of these changes.
Katherine Sale is the AAOS manager of biomedical research & regulation; She can be reached at firstname.lastname@example.org. Jeanie Kennedy is the manager of regulatory and government affairs in the AAOS office of government relations; she can be reached at email@example.com.