FDA guidance offers recommendations for reporting medical device changes

FDA sign

Device makers now have more recommendations and guidance on when they must report modifications made to products on the market.

The materials, published by the U.S. Food and Drug Administration, include updated recommendations for manufacturers of the tools, as well as a new draft guidance for software changes.

“These draft recommendations are intended to help manufacturers determine when a change is significant enough to warrant FDA review, including major changes or modifications to the intended use that could significantly impact safety and effectiveness,” Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, said in an announcement.


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The original guidance was issued in 1997; the new version looks to keep the same structure and format while also providing more clarity.

That clarity includes flowcharts that outline when device makers should submit a report on changes, including labeling, materials, technology, engineering and performance adjustments. For example, if a change is made to improve the safety and effectiveness of a device in response to a known risk, a new 510(k) is needed.

There also are guiding principles, the FDA notes, such as recommendations for developers to “conduct a risk-based assessment in order to determine whether a modification could significantly affect the safety or effectiveness of the device.”

Efforts to ensure the safety and effectiveness of medical devices are on the upswing.

In early June, a bill introduced in Congress would require doctors to report adverse events from medical devices to the FDA. In addition, the planning board for a national medical device evaluation system released a new paper describing how the nation can implement a coordinated network to gather evidence on the safety and effectiveness of medical devices.

To learn more:
- here are the device recommendations
- check out the software guidance

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