FDA Determines Knee Medical Device Compliance Issue

FDA announced that an orthopedic medical device used in the knee should not have been cleared for marketing in the United States

. Menaflex Collagen Scaffold, the medical device was re-evaluated after a FDA report in September 2009 identified problems with the medical device's compliance.

FDA will begin the process to rescind the product's marketing clearance. FDA has requested that the manufacturer, ReGen Biologics Inc., meet with FDA to discuss what data would provide assurances of the medical device's compliance.

The medical device was cleared for marketing by the FDA in December 2008. The medical device has been marketed for the repair and reinforcement of the meniscal tissue.

The report recommended a scientific re-evaluation of the medical device because the administrative record did not supply a basis for the FDA's previous clearance.

The FDA has questioned the compliance of the medical device with substantially equivalent standards. One of FDA's multiple options for medical device clearance is to be substantially equivalent to a product already being marketed with FDA clearance. These already marketed devices are known as "predicate devices." FDA now claims that the medical device is not substantially equivalent, thus affecting the safety and effectiveness of the Menaflex device.

A rescission is an FDA action to revoke a marketing clearance later determined to be erroneous. Once a rescission is implemented by FDA the manufacturer is no longer allowed to market the device in the US. The manufacturer of the medical device must wait, once again, for FDA clearance.

To date there is no indication that explanting the medical device is necessary, however patients who have had this medical device implanted into their knees should speak with their surgeon or other health care professional to determine what is necessary in their individual cases.

Ms. Capote represents businesses with regulatory compliance issues and litigation. She focuses her practice on representing clients before regulatory agencies, such as the Consumer Product Safety Commission, Food and Drug Administration (FDA), Environmental Protection Agency (EPA), Customs and Border Protection (CBP) and United States Department of Agriculture (USDA).

FDA Determines Knee Medical Device Compliance Issue

By: Lisacapote

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