Misbranded & Adulterated Medical Devices – FDA

The following sections provide information on misbranded and adulterated medical devices.

What are adulterated medical devices?

An adulterated medical device is any product that has been corrupted or debased by incorporating an impure or spurious substance. The FDCA has expanded this definition by adding that a product may also be adulterated due to:

• the defective nature of an inherent characteristic of the device itself,
• the conditions surrounding the device, even if there may be nothing intrinsically wrong with the device itself.

Adulterated medical devices have several intrinsic qualities. Namely:

• The device consists of filthy, putrid, or decomposed substances.
• It contains an unsafe colour additive.
• Its strength, quality or purity doesn’t comply with its label.
• It doesn’t conform to applicable established performance safety standards.

In addition to the above, some external conditions will also render a medical device adulterated if:

• The device’s container is made of poisonous or deleterious materials.
• The device was processed or held under unsanitary conditions.
• It’s a banned device.
• It’s an investigational device that is not the subject of an approved investigational device exemption (IDE).
• The manufacturer has refused to be inspected by the FDA.
• The facilities or controls for manufacturing, packaging, storage, record keeping, process controls, or installation don’t comply with relevant standards or conditions.
• It fails to comply with applicable requirements related to its investigational status.
• It’s a class I or class II device that isn’t the subject of a cleared Premarket Notification (510[k]).
• The product is a Class III device that isn’t the subject of an approved PMA, a completed PDP, or an approved HDE.

Which devices are misbranded?

A misbranded product is any device that contains false or misleading labelling. However, as with adulteration, the FDCA has an expanded definition which also includes the following conditions:

• A device may be considered to be misbranded due to the condition of its packaging or labelling
• A device may be deemed to be misbranded due to conditions external to the actual packaging or label.

In this regard, the following packaging and labelling conditions can render a device misbranded:

• The labelling is misleading or false.
• The label doesn’t include any of the following: name and address of the manufacturer, distributor or packer; the quantity or measure of the contents; adequate instructions for use, with necessary user protection warnings; and the established name of the device.
• There is a lack of compliance with any applicable colour additive packaging or labelling requirements.
• The product is hazardous to health if used as instructed in the labelling.
• There is a lack of compliance with the labelling requirements of an applicable standard.
• If the device is restricted or a prescription device, its labelling doesn’t contain the prescribed warning.

In addition, some external conditions may also affect the status of a device. For instance, a device may be misbranded if:

• The marketing materials for the device don’t contain a brief statement of the device’s intended uses and relevant side effects, contraindications, warnings, and precautions.
• It’s made in an establishment that didn’t meet specific registration requirements.
• There is non-compliance with relevant MDR requirements.
• The manufacturer doesn’t comply with the post-market surveillance requirements or with the requirements of a PS order.
• The manufacturer or any distributor failed to meet the tracking requirements.