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August 4, 2010

FDA Proposes Changes to 510(k) Approval Process

The US Food and Drug Administration (FDA) has proposed changes to the 510(k) approval process in an attempt to tighten the regulation of medical devices. Under the plans, the FDA would create a subset for moderately risky devices such as infusion pumps, which would need to be accompanied

By cms admin

The US Food and Drug Administration (FDA) has proposed changes to the 510(k) approval process in an attempt to tighten the regulation of medical devices.

Under the plans, the FDA would create a subset for moderately risky devices such as infusion pumps, which would need to be accompanied by more data for approval.

Other changes include giving the public access to the FDA’s review decisions and device labelling, and clarifying how and when the FDA can pull a 510(k)-approved device off the market.

The recommendations follow a shake-up and external review of the FDA by the independent Institute of Medicine.

A report on the proposals will be open for public comments for 90 days, after which the changes will be adopted.

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