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