Question

Could an intentionally misbranded medical device be considered an adulterated medical device? Why or why not ?

Answer 1

Yes, intentionally misbranded medical device be considered an adulterated medical device based on the provisions of.FD&C Act under Section 501.

Medical devices are subject to the adulteration provisions of the FD&C Act under Section 501.

Drugs and Device Misbranding Provisions

A drug or device is deemed to be misbranded if:

• Its labeling is false and misleading.
• Its packaging does not bear a label containing:
  1. the name of the place of business of the manufacturer, packer, or distributor, and
  2. an accurate statement of the quantity of contents in terms of weight, measure, or numerical count.
  Reasonable variations and exemptions for small packages may be permitted.
• Any word, statement, or other required information is not prominently placed on the labeling or not clearly stated so as to be read and understood by the ordinary individual under customary conditions of purchase and use.
• It is for use by man and contains any quantity of a narcotic or habit forming substance, unless its label bears the name and quantity or proportion of the substance or derivative and the statement "Warning - may be habit forming."
• Its label does not bear adequate directions for use. The label must include warnings against use in certain pathological conditions or by children where its use may be dangerous to health, or against unsafe dosage or methods or duration of administration or application. Adequate directions and warnings must be present when it is necessary to protect the health of the user. Exemptions to this provision may be obtained. The phrase "adequate directions for use" pertains to over-the-counter drugs and device.
• It is dangerous to health when used in the dosage or manner, or with the frequency or duration prescribed, recommended, or suggested in the labeling.
• It does not comply with the color additive provisions listed under Section 706 of the FD&C Act.

Device Misbranding Provisions Added by the Amendments

The Amendments added new authority relating to the misbranding of medical devices. These new provisions state that a device is misbranded if:

• The device's established name (if it has one) or its name in an official compendium, or any common or usual name, is not prominently printed in type at least half as large as that used for any proprietary name or designation. Exemptions from this provision may be granted.
• A restricted device offered for sale in any State uses false or misleading advertising, or is sold, distributed, or used in violation of restricted device regulations under Section 820(e) of the FD&C Act.
• A restricted device manufacturer, packer, or distributor fails to include in all advertisements or other descriptive materials:
  1. a true statement of the device's established name, prominently printed, and
  2. a brief statement of the intended uses of the devices and relevant warnings, precautions, side effects, and contradictions.
• The device commercially distributed without FDA concurrence on a Section 510(k) submission.
• The device is subject to a performance standard and it does not bear the labeling prescribed in that standard.
• There is a failure or refusal to comply with any requirement prescribed under section 518 (Notification and Other Remedies); to furnish any material or information required by or under Section 518; or to furnish any material or information requested by or under Section 519 (Records and Reports on Devices).

The FD&C Act states that a drug or device is misbranded "if its labeling is false or misleading in any particular." "Labeling" includes the label and any other written, printed, or graphic material that accompanies a device and any of its wrappers or containers. Operating and servicing instructions are also regarded as part of the labeling. The labeling must bear adequate directions for use and any warnings needed to ensure the safe and effectiveness use of the device