The public trust manufacturers of medical products to develop and commercialize devices that are safe for humans. There are many types of medical devices varying in complexity, some as simple as contact lenses and others, life saving devices such as a pacemaker. In many cases these medical products perform as expected and last for the duration of the recipient’s lifetime or expected life of the device. Other times they fail and possible reasons for failure include, improper manufacturing, malfunction, breakage or erosion, all possibly resulting in serious injury to the device recipient. Implanted devices are being used for longer periods of time and in younger populations, presenting unique challenges as current devices may not have been designed for such a life span. This makes it difficult for Center for Devices and Radiological Health (CDRH) to communicate risk/benefit to multiple audiences in a way that is timely and balanced.
FDA’s CDRH has a mandate to ensure that new medical devices are safe and effective before they are marketed and monitor devices throughout the product life cycle, including a nationwide postmarket surveillance system. CDRH also has to assure that radiation-emitting products, such as microwave ovens, TV sets, cell phones, and laser products meet radiation safety standards. This mandate is an awesome responsibility presenting many challenges to CDRH who approves or clears a product after reasonable assurance of the safety and effectiveness has been scientifically demonstrated.
Advances in medical device technology have presented many challenges to CDRH. Adverse events are widely under-reported by users and numerous reports are made with inadequate information about how the device was used (condition/circumstance) and what may have caused the problem. This means that there is an inherent difficulty in identifying the specific device involved. Part of the problem is further compounded by the miniaturization of medical devices which are designed smaller and vary in complexity. This means that there are fewer margins for error. From surgical sutures and contact lenses to prosthetic heart valves and diagnostic imaging systems, these require that attention of qualified reviewers for an ever increasing pre-marketing submission environment.
The medical device market can be characterized as an industry where innovation, advancement, rapid growth and the complexity of devices are increasing. Many of these devices presented to CDRH are the first of their kind, such as a robotic arm that can operate a variety of surgical tools with tremendous precision. Other high-tech devices are designed to prevent, diagnose or treat cancer, heart disease, impaired vision and hearing, and other health problems. Current devices lack unique and universal identifiers and healthcare providers generally do not document device use in patient records. Manufacturers are continually producing modified versions of their products which mean that multiple versions may exist.
In the current economic climate, many firms are facing increasing competition and realizing that new FDA guidances and regulations are increasing operating costs. This has resulted in device firms being acquired by other companies in an attempt to gain economies of scale and solidify core competencies. There are cases of devices being used “off-label,” used by non-professionals and a shift to medical devices for home use, such as diagnostic tools. These changing realities present CDRH which more challenges in terms of post-market surveillance and with a limited field of resources; the agency is clearly unable to deliver on all fronts.
SUMMARY Government Accountability Office (GAO)
REPORT LINK: GAO-09-190 January 15, 2009
Medical Devices: FDA Should Take Steps to Ensure That High-Risk Device Types Are Approved through the Most Stringent Premarket Review Process
The Food and Drug Administration (FDA) within the Department of Health and Human Services (HHS) is responsible for oversight of medical devices sold in the United States. Regulations place devices into three classes, with class III including those with the greatest risk to patients. Unless exempt by regulation, new devices must clear FDA premarket review via either the 510(k) premarket notification process, which determines if a new device is substantially equivalent to another legally marketed device, or the more stringent premarket approval (PMA) process, which requires the manufacturer to supply evidence providing reasonable assurance that the device is safe and effective. Class III devices must generally obtain an approved PMA, but until FDA issues regulations requiring submission of PMAs, certain types of class III devices may be cleared via the 510(k) process. The FDA Amendments Act of 2007 mandated that GAO study the 510(k) process. GAO examined which premarket review process–510(k) or PMA–FDA used to review selected types of device submissions in fiscal years 2003 through 2007. GAO reviewed FDA data and regulations, and interviewed FDA officials.
In fiscal years 2003 through 2007, as part of its premarket review to determine whether devices should be permitted to be marketed in the United States, FDA:
(1) Reviewed 13,199 submissions for class I and II devices via the 510(k) process, clearing 11,935 (90 percent) of these submissions;
(2) Reviewed 342 submissions for class III devices through the 510(k) process, clearing 228 (67 percent) of these submissions; and
(3) Reviewed 217 original and 784 supplemental PMA submissions for class III devices and approved 78 percent and 85 percent, respectively, of these submissions.
Although Congress envisioned that class III devices would be approved through the more stringent PMA process, and the Safe Medical Devices Act of 1990 required that FDA either reclassify or establish a schedule for requiring PMAs for class III device types, this process remains incomplete. GAO found that in fiscal years 2003 through 2007 FDA cleared submissions for 24 types of class III devices through the 510(k) process. As of October 2008, 4 of these device types had been reclassified to class II, but 20 device types could still be cleared through the 510(k) process. FDA officials said that the agency is committed to issuing regulations either reclassifying or requiring PMAs for the class III devices currently allowed to receive clearance for marketing via the 510(k) process, but did not provide a time frame for doing so.