FDA Proposes Safety System to Monitor Medical Devices

According to Drug Watch, the U.S. Food and Drug Administration (FDA) is proposing a new safety system to monitor medical devices. The new plan would entail unique device identifications (UDIs) that could be used to track the devices. 

UDIs could help identify defective devices sooner, leading to quicker recalls. The current system of reporting these defects don’t always address specific brands. And many of these cases go underreported. 

In addition, the FDA would like to improve the online database that provides information pertaining to medical devices to the public. This would allow doctors, for instance, to know right away if a product has been recalled. As a result, they would stop using or recommending that product to patients. 

It will take a few years, of course, to implement the UDI plan after the proposal has been approved. However, devices considered the most dangerous (Class III), will have a year from the date the law goes into effect to add the UDI. 

Class II devices tend to have the highest report of injury to patients. Products in this category, such as transvaginal mesh and knee and hip implants must add UDIs within three years of the law’s passing.  

Contacting a New York Medical Devices Attorney 

At Gacovino Lake & Associates we have formed a dedicated network of medical device attorneys that serve clients nationwide. Our New York office serves residents of the five boroughs with their auto accident, medical malpractice, defective drug, premises liability, and Workers’ Compensation claims. For experienced help with your medical malpractice claim, contact us today – 1-800-246-4878.

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