FDA Issues Draft Guidance on Device Changes that Trigger New Review
The Food and Drug Administration has issued draft guidance that clarifies the kinds of changes or modifications to a previously cleared 510(k) device that trigger the need for a new premarket submission, such as changes regarding labeling, the technology used…
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in the device, performance specifications, manufacturing changes, etc. To legally market a device, manufacturers must submit a premarket notification or 510(k) demonstrating that a new or modified product is substantially equivalent to another legally marketed medical device. When manufacturers make changes or modifications to a device after FDA clearance that could significantly affect the product’s safety or effectiveness or constitute a major change to the intended use of the device, another 510(k) must be submitted.