The medical device industry faces a number of significant challenges. Federal health care reform, unpredictable U.S. regulatory pathways and an uncertain economic climate are exerting a tremendous amount of pressure on the entire industry. Various segments of the orthopaedic market have been hit especially hard as procedure numbers drop and payors issue more restrictive coverage guidelines. In addition, the 510(k) pathway is no longer a predictable process for orthopaedic devices. Today, more so than ever, we need to stay vigilant within this changing landscape. This article will review the current 510(k) environment, economic considerations and study-design considerations for the orthopaedic industry.
Nearly 60% of the medical devices assigned to FDA’s orthopaedic review panel are marketed via the premarket notification (510(k)) process. Until recently, the 510(k) process had been relatively constant and predictable for manufacturers introducing new or modified devices. Today, decision timelines for 510(k)s are taking 25% longer compared to five years ago. FDA conducted an internal evaluation of the 510(k) process and published their preliminary findings in August of last year. On January 19, 2011, they announced the first definitive changes to the 510(k) clearance process based on over 12 months of public meetings, town hall meetings, an internal task force report and scores of comments submitted to the docket from industry, the medical profession and consumer groups.
Some of the key activities affecting the orthopaedic industry include:
- Increasing the predictability of requirements through guidance as to when clinical data will be needed to support a premarket notification (510(k)).
- Relying on a network of internal/external experts to serve as a “Center Science Council” to review new technologies and ensure science-based decision making.
- Creating an expansive database for devices to include labeling, detailed descriptions of some devices, and a summary basis for clearance.
- Communicating agency expectations to industry through an expansion of their guidance programs which will include a Notice to Industry: a shorter, two-page summary guideline or policy for certain devices or technologies.
- Rescinding 510(k) clearances of inappropriate predicates (such as those that have been removed from the market due to safety or efficacy concerns to make them ineligible as predicates for newer devices. FDA noted their authority to rescind clearance does not have to be codified.
While these steps continue to evolve, it is clear that the increasing demand for manufacturers to provide adequately powered clinical datasets demonstrating the safety and effectiveness of 510(k) products will continue.