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FDA to Change Medical Device Procedure

medical device

The Food and Drug Administration (FDA) plans to make changes in its current system of approving medical devices. Public safety activists have been criticising the system as unsafe. The proposed changes will give the FDA greater authority to revoke ineffective or unsafe products.

Not surprisingly, the device makers’ lobby has protested against the proposed changes. They say device reviews will become more expensive and longer, costing jobs and hurting innovation. The non-partisan group Institute of Medicine will advise the FDA on the changes.

Currently, the 510(k) system, established in 1976, is used to give quick approval to products that function similar to already existing devices. Thus, it is favored by device makers, as the path to clearance is cheaper and faster, compared to the process for new devices, which involves rigorous testing.

However, the FDA’s critics point out that even high-risk devices like heart pacemakers are getting approved under the 510(k) system without thorough scrutiny and testing. The 510(k) procedure clears around 4,000 devices annually, compared to around 50 devices under the stringent system for novel products.

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