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510(k) Guidance Overhauls Agency Risk vs. Benefit Review
For the first time, manufacturers submitting 510(k)s would have to show FDA reviewers that the risks and benefits of a candidate device are acceptable and substantially equivalent to those of the predicate device, according to draft guidance issued last week.

Manufacturers should be able to demonstrate the likelihood that a risk or beneficial effect will occur and how widely it will occur, the FDA says. For example, a modified device may cause a benefit in only a few patients, or broadly across the patient population, and a specific risk may be rare or common. Those situations would raise different considerations in reviewing a 510(k) submission, the agency adds...

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