Medical Device Patient Safety Act Proposes Two-Step Change to Oversight of Devices
Medical Device Law Update
In mid-December of 2011, following the recommendation of the Government Accountability Office (GAO), a bipartisan group of senators introduced the Medical Device Patient Safety Act. According to the GAO, the Food and Drug Administration's (FDA) lack of oversight of medical devices once they are on the market has created a high-risk situation for consumers.
Under the existing framework, the FDA has limited ability to monitor medical devices once they are cleared under the 510(k) process. As a result, according to the GAO, faulty products are not identified quickly enough. The Act proposes a two-step change in order to meet two goals, as identified by Sen. Chuck Grassley (R-Iowa): (1) to improve the recall process and (2) to enhance post-market surveillance tools.
The Act's first change would require the FDA to track and trend medical device recall data. Currently, the FDA has the authority to track recall data, but is not required to do so. Under the Act, a program to routinely and systematically assess "(1) information submitted during a device recall and (2) information regarding a correction or removal of a device" would be created. Additionally, the FDA would be required to "(1) assess information submitted to proactively identify strategies for mitigating health risks presented by defective or unsafe devices and (2) develop explicit criteria of assessing whether the recall was done effectively." This charge appears to give the FDA tremendous freedom in determining what constitutes an effective recall.
The second change proposed by the Act would allow the FDA to grant conditional clearance for devices pursuant to the 510(k) process. The Act requires post-market safety evaluations of these devices, including data collection, labeling information, and post-market studies. If the conditions of the clearance were not met, the FDA would have the authority to rescind the device's clearance. The language of the Act is unspecific as to the particular devices to which the conditional clearance applies; Sen. Grassley's information sheet indicates only that it is meant for devices that may have safety concerns.
While this change does give the FDA expanded authority over 510(k)-cleared devices, it could potentially represent a reduction in the burden of pre-market data collection. Its vague language, however, could also be used by the FDA to make conditional clearance the norm. The Act's goal of better protecting patients while still getting medical devices to the market quickly is certainly worthy. But its apparent grant of broad discretion to the FDA in pursuing those goals raises questions as to how the FDA would implement its proposed changes.