FDA Calls For Full Risk Reviews For Device Changes In 510(k) Modifications Draft
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thoroughly consider unintended outcomes of changes they make to already-cleared devices, says a new, highly anticipated draft guidance on 510(k) modifications.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.
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510(k) Modifications Guidance Shows FDA Focus On Least- Burdensome Principle, Routine Risk Tests
A final 510(k) modifications guidance released from US FDA contains at least nine changes in emphasis from an August 2016 proposal. It enunciates the agency's plan to abide by "the least burdensome principle" in evaluating sponsors submissions for changes, and it recommends that any decision by a company not to submit a new 510(k) after a device alteration be routinely verified and validated.
Updating Your Device In The EU? It Isn't Always Clear When You Need To Tell The Notified Body
In the EU, when do manufacturers need to tell notified bodies about an extension to their product line before placing the updated devices on the market? Is there a definitive answer, or is more clarity needed? Experts weigh in.
Industry Urges FDA To Distinguish Between 510(k) Modification Factors
Industry groups and companies said US FDA's August draft guidance is inappropriately intermixing two different standards for determining when a new 510(k) needs to be submitted for a device modification. Respondents to the draft guidance on 510(k) modifications are also looking for more clarity on FDA's expectations for companies to assess how cumulative changes to a device might trigger the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.