From AAPD Policy Intern Zoe Levenson (6.9.2010):
Will People with Disabilities Benefit?
On June 2, 2010, AAPD attended a briefing by trade association AdvaMed on the implications of the Food and Drug Administration (FDA)’s market review process. The briefing focused specifically on the 510(k) process for devices of moderate risk and included some life-sustaining technologies. Speakers included Janet Trunzo, AdvaMed’s Executive Vice President of Technology and Regulatory Affairs, who gave an overview of the review process, and Dr. Roshan Shah from the American Academy of Orthopaedic Surgeons, who discussed the implications of the process for patients and physicians.
The FDA’s 510(k) process was established under the Medical Device Amendments of 1976 to achieve two goals: make safe and effective devices available to consumers; and to promote innovation in the medical device industry. Medical devices are divided into three classes, from low-risk (products like bandages, scales, and mechanical wheelchairs), to moderate risk (such as contact lenses, power wheelchairs, and sutures), to the highest-risk, life-sustaining technologies (such as permanent implants and pacemakers). The moderate-risk technology is the group that undergoes 510(k) review, that is, things like contact lenses, power wheelchairs, and sutures. Thousands of such products are cleared through this process every year.
Dr. Shah talked about the benefits of the 510(k) process for patients, stating, “Incremental improvements can advance technology while having substantially equivalent safety and efficacy profiles.” For example, devices can be adapted to exclude allergens or to fit patients with a variety of body types. Another result of the process has been more durable and longer-lasting technology. This allows us, as consumers of medical devices, to obtain the best technology in a safe way. It also allows physicians to provide patients with technology tailored to their specific needs. As a whole, the process seems to support high standards and consistency while allowing for adaptability in the medical technology market.
FDA has been publicly revising the 510(k) process since February 2010 and is looking to complete their review by September 2010. Between February and March, the FDA received open written consumer feedback, and the Institute of Medicine (IOM), which is also participating in the review process, is currently holding public hearings regarding changes to the process. Following these hearings, they will make their own recommendations to the FDA. According to Trunzo, “The basic structure of the 510(k) process is sound, but every process can be improved.” AdvaMed expressed hope that the process would improve its clarity and consistency, making it easier for the FDA and medical device manufacturers to work together for premarket clearance.
What do you think of the FDA’s premarket review of items like bandages, wheelchairs, and pacemakers? Is it helpful to the medical device market? Do you think it slows down the introduction of new technology? Should there be more consumer involvement? Do you think the usability and accessibility concerns of people with disabilities are considered enough in development of medical devices?
More about the 510(k) process at: http://www.fda.gov/medicaldevices/deviceregulationandguidance
More on AdvaMed’s position on technology and regulatory issues at: http://www.advamed.org/MemberPortal/Issues/FDA/
More on the Institute of Medicine (IOM) and the 510K process at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2009/ucm183497.htm