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Notice: Categorization of Therapeutic Products at the Device / Drug Interface
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(PDF Version - 20 K)May 31, 2012
Our file number: 12-109010-767
Subject: Categorization of Therapeutic Products at the Device / Drug Interface
Application
This notice applies to therapeutic products at the medical device and drug interface where the applicable regulatory framework is not immediately apparent.
Context
The definitions of "drug" and "device" stated in the Food and Drugs Act (included in the Appendix to this notice) provide the basis for Health Canada's categorization of these two product lines. Health Canada interprets these definitions in a manner that considers not only how a product achieves its therapeutic function, but also how its composition and characteristics are both represented and perceived in the marketplace. The concept of mode of action (for example, pharmacological, mechanical, etc.) is considered as just one of the factors upon which current categorization decisions are based. It is not a necessary condition that a device or drug has a particular mode of action, as this concept does not appear explicitly in either definition.
Health Canada acknowledges that its application of these definitions has evolved. Not all previous decisions will be indicative of how these products will be categorized in the future. To enhance the transparency of these decisions, Health Canada will develop a guidance document on product categorization at the device/drug interface. This guidance will clarify Health Canada's interpretation and application of the definitions, and will expand upon the influencing factors for categorizing these types of products.
Additional Information
For questions on the categorization of devices and drugs, please contact:
Drug-Device-Classification-Drogue-Instrument@hc-sc.gc.ca
Appendix
Definitions of "Device" and "Drug" in the Food and Drugs Act
Section 2 of the Food and Drugs Act ("the Act") defines a device and a drug as follows:
"device" means any article, instrument, apparatus or contrivance, including any component, part or accessory thereof, manufactured, sold or represented for use in
- the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or its symptoms, in human beings or animals,
- restoring, correcting or modifying a body function or the body structure of human beings or animals,
- the diagnosis of pregnancy in human beings or animals, or
- the care of human beings or animals during pregnancy and at and after birth of the offspring, including care of the offspring,
and includes a contraceptive device but does not include a drug;
"drug" includes any substance or mixture of substances manufactured, sold or represented for use in
- the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or its symptoms, in human beings or animals,
- restoring, correcting or modifying organic functions in human beings or animals, or
- disinfection in premises in which food is manufactured, prepared or kept;
