The Food and Drug Administration (FDA) vowed that it will deliver warnings regarding recalled medical devices to the public in a more timely manner in 2017.
The FDA defines a medical device recall as a correction or removal action to address a problem with a device that violates FDA law. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.
When the FDA learns of a company’s recall or removal action regarding a medical device, the agency reviews the strategy the company poses to address the problem and the health hazard it poses to consumers. Then the agency assigns the recall a classification, such as I, II or III, based on the relative degree of risk. A Class I recall is the most serious type of recall and is used for medical devices in which there is a reasonable chance that if used, the product will cause serious health problems or death.
In years past, the FDA would post device recall information only after the agency announced the company’s announcement of a correction or removal of a device. But starting this year, the agency has started posting the information in its Center for Devices and Radiological Health’s (CDRH) Medical Device Recalls Database at the time the company notifies the FDA that it is taking corrective action or removal action.
The process for reporting a correction or removal will not change. The FDA will continue to work with industry and state partners to publish press releases and other public notices about recalls that may potentially present a significant or serious risk to the consumer or user of the product.
Source: Orthopedics This Week