Is the FDA Doing Anything to Stop Companies from Hiding Medical Device Injuries?

In October, the Minnesota Star Tribune reported on a story involving US Food & Drug Administration (FDA) regulations and how they may be enabling companies to cover up medical device injuries. It appears that the Star Tribune story touched a nerve over at the FDA, leading to changes that could help prevent medical device manufacturers from sweeping patient injuries under the rug.

What Is the FDA Doing to Stop Companies from Covering Up Medical Device Injuries?

In the wake of the claims brought up in the Star Tribune article, the FDA created a new website that enables patients to assist with the regulatory process. The name of the website is Allegations of Regulatory Misconduct. The site includes an online form, which allows any person to submit a claim against a medical device manufacturer or advertiser for alleged violations of industry regulations or laws regarding product safety.
The purpose of the website is to make sure that the FDA is aware of safety concerns that might have otherwise escape the regulatory agency’s attention. By ensuring potential risks are identified, the FDA can better protect the public. This includes investigating the incidents and taking the steps necessary to protect patients from dangerous medical devices.

Here are the types of claims that can be submitted through the FDA’s new website:
•    If a manufacturer falsifies documents or hides information from the FDA.
•    The export certificate is falsified or forged to import the device into the US.
•    Device manufacturer does not conduct required follow up investigations after safety concerns are reported to the FDA.
•    A medical device that doesn’t meet legal requirements is imported into the US by a manufacturer.
•    A manufacturer does not register their medical devices with the FDA.
•    A company’s marketing practices violate FDA-approved rules for advertising.
•    A manufacturer markets a device without FDA clearance.

It’s encouraging that the FDA seems to be making strides to correct issues that could be endangering patients’ lives. However, there’s still a long way to go before medical device injuries are a thing of the past. For those who have been the victim of an injury that may have resulted from a medical product defect, there are options for getting the help they and their families need. This can include but is not limited to filing a product liability claim.

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