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Final Guidance Documents: When to submit new 510(k)s for devices and software

FDA has issued final guidance documents to help medical device companies determine when to submit new 510(k)s for hardware and software.

The agency will hold a webinar to explain the changes to industry on November 16, 2017.

On October 25, 2017, the U.S. Food and Drug Administration published final guidance documents pertaining to when manufacturers should submit a new 510(k) when changes have been made to a medical device or to medical device software. These guidance documents closely follow what FDA issued back in 2016, and are intended to make "when to submit" decisions more consistent, easier, and more predictable.

A New 510(k) Is Required When...

Based on the final guidance documents, a new 510(k) may be required for a previously cleared class 2 medical device when there have been changes to labeling, technology, engineering, performance, or materials. This includes modifications intended to improve the device's performance.

When it comes to software, FDA requires the submission of a new 510(k) when the change introduces a new level of risk or significantly affects functionality or performance specifications tied to the device's intended use.

FDA does NOT require a new 510(k) for software changes intended to address cybersecurity.

IUVO Consulting, LLC helps companies submit 510(k) pre-market notifications to FDA. To speak with us regarding your device or software, please contact us by email: or by phone (757) 514-1589.

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