MicroSeal Hip System Problems Result in Warning Letter to Signal
Signal Medical Corp. has received a warning letter from federal regulators about a failure to obtain required premarket approvals for a hip replacement system before placing the product on the market, potentially exposing consumers to a risk of injury from unknown and untested device hazards.
Earlier this month the FDA released a letter sent to Signal Medical Corp. after discovering the company began selling MicroSeal Total Hip Acetabular Systems with significant changes to the device without the proper FDA approval.
The MicroSeal Total Hip Acetabular Systems are non-cemented total hip replacement devices that are implanted by physicians in those with failing hips. The devices are sold in various sizes to accommodate the patient’s bone structure.
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On July 31, 2014, the FDA began inspecting the firm’s Michigan plant, where investigators identified multiple regulatory violations. The investigators discovered that Signal had made significant changes to the device, including the addition of a hood liner, adding new sizes of the device, changing the shell design, and modifying the liner without clearing the changes with the FDA before introducing it to the market for distribution and sale.
The FDA’s report indicates that Signal did not add these changes and additional sizes of the device in their prior premarket approval application. Failure to submit a premarket notification for device modifications to the FDA is a direct violation under the Federal Food, Drug, and Cosmetic Act (the Act) 21 U.S.C. and the company could face penalties if not handled within the appropriate timeframe and manner required under the laws.
In the FDA’s warning letter to Signal Medical Corp., the company was given 15 days to respond to the violations with steps the firm has taken to correct the noted violations as well as an explanation of how the company plans to prevent similar future occurrences. The FDA notes in the warning that if the company fails to comply with these demands that regulatory action could be taken without further notice to include seizures, injunctions, and civil money penalties as well as public warning letters about the devices so that the federal agencies take the information into account when considering the award of contracts.
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