Decision tree
Heading
Surgically invasive - long-term use and implantable
Body
Long-term use and implantable surgically invasive medical devices may be intended to:
- be placed in the teeth and to undergo a chemical change in a patient's body
- undergo a chemical change in a patient's body (other than a device that is intended by the manufacturer to be placed in the teeth)
- have a biological effect
- administer medicine to a patient
- be wholly, or mostly, absorbed by the patient's body
- be used in direct contact with the heart, the central circulatory system, or the central nervous system of a patient.
The term 'placed in the teeth' includes a medical device that is intended to penetrate a tooth but does not include a medical device that is intended to penetrate a tooth and enter the gum or bone beyond the tooth.
Question
Which intended purpose is applicable for your long-term or implantable surgically invasive device?