A “Disastrous” Draft? Device Firms Take Issue With 510(k) Modifications Guidance
This article was originally published in The Gray Sheet
Draft guidance on when to submit a 510(k) for a change to a previously cleared device could increase the number of submissions by two- or three-fold, device makers say. Some call for draft to be withdrawn.
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Industry groups and companies said US FDA's August draft guidance is inappropriately intermixing two different standards for determining when a new 510(k) needs to be submitted for a device modification. Respondents to the draft guidance on 510(k) modifications are also looking for more clarity on FDA's expectations for companies to assess how cumulative changes to a device might trigger the need for a new submission. But overall, firms support the current draft more than the agency's abandoned 2011 attempt to revise its policy.
US FDA wants sponsors to complete risk-based assessments and thoroughly consider unintended outcomes of changes they make to already-cleared devices, says a new, highly anticipated draft guidance on 510(k) modifications. This is true whether alterations are made by manufacturers to improve safety or effectiveness, enhance labels, change technology or engineering, or to upgrade materials in a device.