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Understanding Medical Device Requirements


Millions of Americans rely on medical devices to either save their lives or improve the quality of their lives every year. While most medical devices perform properly and provide doctors with the means to maintain their patients’ quality of life, other devices fail and either do not help the patient, or tragically, actually cause the patient further harm. As new devices have been brought to the marketplace, manufacturers push to have increasingly risky devices approved and unfortunately, consumers suffer the consequences.

What Example of Questionable Medical Devices was Recently in the News?

The South Florida Sun Sentinel recently reported that some patients are questioning how the Food and Drug Administration (FDA) approves medical devices. More specifically, there is a question of how stringent the pre-market procedures can possibly be as the bulk of medical devices that are offered to patients don’t go through human testing unlike pharmaceutical drugs.

How Often is the FDA Notified of Potentially Defective Medical Devices?

According to the FDA itself, the department receives hundreds of thousands of reports each year detailing the deaths, serious injuries, and malfunctions of medical devices. These suspected medical device injuries are obviously based on self-reporting and, therefore, numbers may be much higher in actuality.

What Are the Postmarket Surveillance Tools Used by the FDA?

The FDA utilizes Medical Device Reporting as a primary method of monitoring how medical devices perform, detect potential safety issues, and assess benefit-risk analysis. Specified reporters are actually required to submit certain types of reports for adverse events and product problems.

What Are These Specified Medical Reporters and When Are They Required to Report to the FDA?

  • Manufacturers. Manufacturers are required to report to the FDA whenever they become aware that their device has malfunctioned in a way that will likely cause or contribute to a death or serious injury if the malfunction happens again, or whenever the manufacturer learns that its device may have actually caused or contributed to a death or serious injury.
  • Device user facilities. This category of reporters includes places patients may actually visit for treatment and help such as hospitals, nursing homes, and/or outpatient treatment facilities. These user facilities are required to report a suspected medical device-related fatality to both the FDA and the manufacturer.
  • Importers. Importers must report to both the FDA and the manufacturer upon learning that one of their devices may have caused or contributed to a death or serious injury. The importer is only required to report to the manufacturer if it learns the imported devices have malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to reoccur in the future.

Have Your or a Loved One Been Injured as a Result of a Defective Medical Device?

Defective medical devices can lead to tragic circumstances, but you don’t have to suffer a second tragedy by suffering without the compensation you deserve. If you believe that you or a loved one has been injured due to the fault of someone else’s medical negligence, contact the experienced Miami medical malpractice attorneys of The Pendas Law Firm today.

The Pendas Law Firm also represents clients in the Tampa, Fort Lauderdale, Orlando, Fort Myers, Daytona, Jacksonville, and Bradenton areas.




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