FDA issues draft guidance on postmarket issues

The FDA today released a pair of draft guidances on postmarket requirements for certain devices.

The first guidance was written to help manufacturers of certain Class II (moderate-risk) and Class III (high-risk) devices for which the agency has issued a postmarket surveillance (522) order. The FDA may issue a 522 order at any time in the lifecycle of such devices that meet any of the following criteria:

A failure with the device would be reasonably likely to have a serious adverse health consequence. The device is expected to be used significantly in pediatric populations. The device is intended to be implanted in the human body for more than one year. The device is intended to be life-sustaining or life-supporting and used outside of a healthcare facility.

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