Adulterated Device
What does it mean if a device is adulterated?
An adulterated device is any device that:
- contains a putrid, filthy, or decomposed substance
- has a container composed (wholly or partly) of a harmful or toxic substance
- is packed, prepared, or held in unsanitary conditions
- has a strength or quality that differs from that which it claims to have
All medical devices are subject to the adulteration provisions of the Federal Food, Drug, and Cosmetic (FD&C) Act under section 501, which labels adulterated devices as also being:
- Class III medical devices that fail to conform to the requirements of their approved premarket approval application
- Banned devices
- Devices that are subject to a performance standard but do not comply with all the standard’s requirements
- Noncompliant with an investigational device exemption (IDE)
- In violation of good manufacturing practice requirements
By these criteria, a device may be considered adulterated even if there is nothing wrong with the device itself.
What happens if a medical device is adulterated?
If a device is considered adulterated, it no longer meets the regulations of a medical device and is considered unsafe for human use. The FDA may initiate legal action against the device or its responsible individuals or request that the device be destroyed or brought to comply with the FD&C Act.