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Old Devices Require New FDA Approval, Causes Concern

The New York Times’ Well blog reports that certain medical devices are under scrutiny due to the fact that they were not properly evaluated by the FDA for approval. The reason is because these “high-risk” devices, which “sustain human life, are instrumental in preventing harm, or pose an unreasonable risk to patients,” were invented and put on the market before 1976, when the FDA began regulating devices. The devices requiring approval include “external pacemakers, access tubes implanted in blood vessels, a component of a lung device used for newborns, dental devices that are implanted near the brain, and screw systems used in spinal surgery.” The FDA has responded by stating that they will “downgrade” some of these devices to a non-“high-risk” category and that, “in situations where additional information is needed, the agency may request additional data from the company to ensure that reasonably safe and effective devices are coming to market.”

Read it in The New York Times’ Well blog.