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A “Disastrous” Draft? Device Firms Take Issue With 510(k) Modifications Guidance

Draft guidance on when to submit a 510(k) for a change to a previously cleared device could increase the number of submissions by two- or three-fold, device makers say. Some call for draft to be withdrawn.

Device makers say FDA’s new draft guidance on when to submit a 510(k) for a change to a previously cleared device is overly prescriptive and will drastically increase the number of submissions to a level beyond the agency’s already strapped review capacity.

Once finalized, the document would replace 1997 guidelines, which had caused some confusion among firms about when a new 510(k) was needed and when minor changes to a device could simply be documented internally by a company. When FDA issued the updated draft guidance on July 27, the agency said its intent was largely to clarify existing policies

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