The FDA requires post-market surveillance for any Class II or Class III device in the following circumstances:
- Failure of the device would likely have serious adverse health consequences
- The device is intended to be implanted in the human body for over one year
- The device is a life-sustaining or life-supporting device used outside a device user facility
- The device is expected to have significant use in pediatric populations
The FDA can order prospective post-market surveillance of a device for up to 36 months, unless the manufacturer and FDA agree on an extension. The FDA can also require a period greater than 36 months if the device will be used in the pediatric populations and a longer assessment of the device’s impact on patient growth and development is necessary.
Failure or refusal to comply with a requirement for post-market surveillance will render the device misbranded. Violations may lead to enforcement actions including seizure of product, injunction, prosecution and/or civil money penalties.
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