The Archives of Internal Medicine recently published a study of the 113 medical device recalls issued from 2005 through 2009 that the Food and Drug Administration (FDA) deemed life-threatening or very serious hazards. Most of the devices had been reviewed under a less stringent review process, or some devices were exempt from any FDA regulation.
The Centers for Devices and Radiological Health (CDRH) issued 55 recommendations last year and now intends to take 25 actions to improve the review process for medical devices. The actions can be divided into guidance, internal and administrative matters, programmatic and regulatory actions and issues to be referred to the Institute of Medicine (IOM). The FDA plans to implement the 25-point plan this year. The agency hopes the plan will support innovation while delivering technology safely and effectively to patients.
510(k) Approval Process
The approval process for devices that are substantially equivalent to another lower risk device already legally marketed is referred to as a 510(k) process. It is used for devices such as certain catheters or diagnostic imaging devices. Most of the recalls in the study were for devices that gained approval under the 510(k) process.
Actions in the plan providing new guidance for 510(k) review include clarification:
- Which changes warrant submission of a new 510(k) and which modifications are eligible for a special 510(k), which allows the manufacturer to declare conformance to design controls without providing the data
- Of the process for appealing CDRH decisions
- Regarding when clinical data should be submitted in support of a 510(k) application
Additional Actions
The plan also calls for the establishment of a new Center Science Council of senior FDA experts, in order to oversee the development of timely and consistent decision making. One action to be referred to the IOM is the defining of the scope and grounds for exercise of CDRH authority to rescind, either fully or partially, 510(k) approval.
In the meantime, as the review and approval process is streamlined and improved, anyone who has been injured by a defective medical device should contact an attorney. Whether a diagnostic device, implanted device or other device, the injured patient may be entitled to compensation for medical expenses and lost wages.
