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FDA identifies hospitals non-compliant with medical device reporting standards

Posted on Thursday, January 5th, 2017 at 12:49 pm by Williams Hart   

At least fifteen hospitals across the United States failed to comply with the medical device reporting requirements, according to the FDA.

The FDA issued a Form FDA 483 to some prominent hospitals, including Massachusetts General Hospital and New York Presbyterian Hospital, for not promptly reporting deaths and injuries related to medical devices pursuant to 21 CFR Part 803. Under the federal regulation, user facilities, such as hospitals and health centers, have only ten days to submit reports about deaths of patients and serious injuries linked to medical devices to its manufacturer and the FDA. The rule also states that a user facility should maintain a medical device event filing system, which can be inspected by FDA. Out of 17 hospitals, 15 medical centers reportedly demonstrated failures to comply with the federal rule following FDA nationwide inspections. The inspection was initiated last December 2015.

If you or your loved one has been physically injured due to an accident involving a power morcellator, you may be entitled to a monetary claim. Our lawyers at Williams Hart have the experience and skills to properly represent you in court. Get in touch with us at (888) 220-0640.


Federal agency to assess testosterone supplements’ side effects

Posted on Friday, July 25th, 2014 at 8:52 am by Williams Hart   

A committee has been formed by the U.S. Food and Drug Administration (FDA) to investigate the studies that link testosterone supplement use of men with cardiovascular problems, Fierce Pharma reported on July 22.

This coming September, the Bone, Reproductive, and Urologic Drugs FDA group and a committee from Drug Safety and Risk Management will reassess the two recent studies that claimed testosterone supplement use may increase the risk of heart-related problems. Last June, the FDA required testosterone supplement makers to place a warning  on products. Cases against testosterone makers have already been collated by judges in Chicago.

Suffering heart-related problems from using testosterone supplements may result in great financial loss due to expensive treatment needed for recovery. However, if this happened to you, the lawyers of Williams Hart may possibly help you recover your loss by pursuing damage claims from negligent parties. Learn more about your legal actions today by calling (713) 352-7071.

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