Skirt of medical devices after the evaluation of the FDA previously approved

May 4, 2012 /24-7PressRelease / -devices of the defective implant hip and transvaginal mesh devices were placed on the market despite significant concerns about the security of previous models. And thousands of Americans have been injured as a result. Unfortunately, a gap in the Federal Act may be to blame.

By law, the Food and Drug Administration is not required to review or approve medical devices which are "substantially equivalent" previously approved models, as long the previous model was not removed from the market pursuant to an order of the Court or FDA. As previous models of the aircraft have been approved and still available, the Act allowed new devices to skirt past the FDA without evaluation.

However, some regulators require the Congress to change that. Since February, controller of medical-device head of the FDA asked the Congress to fill this gap, indicating that a medical device is five times more likely to be recalled to have security problems if it is based on a previous model that had a known design flaw.

His remarks came only a few weeks after the House Democrats introduced a bill that would allow the FDA to reject medical devices if previous models had been subjected to withdrawals of manufacturer. Bill proponents say that the change will go a long way towards the protection of the safety and health of patients.

Manufacturers of medical devices, however, see the proposal as unnecessary regulation. The Advanced Technology the Medical Association, which is for manufacturers of medical devices, said that the Bill "not help the patient safety."

In addition, most companies choose to issue a voluntary recall before that their products are submitted to the FDA or the Court.

No surprise, as the promoters of the Bills in profound disagreement. Each year, on average, FDA approves 28 medical devices whose design is based on a model already recalled. While not all prove to be dangerous or notorious as the implant hip DePuy or mesh of transvaginal Johnson & Johnson, many have still cause serious injury.

It remains to be seen what Congress will take action. Additional regulations and formalities can impair the ability to move medical devices on the market to help those in need. On the other hand, without proper assessment, defective devices could and prove detrimental to the consumers they are supposed to benefit.

Article provided by Friedman, Hirschen & Miller, LLP
Visit us at the www.friedmanhirschen.com

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