Grassley Wants More Active FDA Oversight Of 510(k) Modification Decisions
This article was originally published in The Gray Sheet
Executive Summary
Sen. Chuck Grassley, R-Iowa, is questioning why FDA does not play a more active role in determining when a change to a device requires a new 510(k)
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Legislators looking for weak spots in FDA's device pre-market review program have honed in on a perceived loophole that allows firms to change existing 510(k) products without notifying FDA