Hoping to increase the transparency of its decision-making processes, the “Canadian FDA” is developing guidance to clarify what factors it takes into account when determining whether a regulated medical product is to be considered a device rather than a drug, and vice versa.
In announcing the project in a public notice dated May 31, Health Canada said the guidance will apply to therapeutic products “at the medical device and drug interface where the applicable regulatory framework is not immediately apparent.”
The agency further explained that it interprets the definitions of drugs vs. devices 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.”
Health Canada acknowledged that its understanding of the difference between drugs and devices has evolved—and is still doing so. “Not all previous decisions will be indicative of how these products will be categorized in the future,” the notice reads, adding that the coming guidance will “expand upon the influencing factors” for categorizing regulated medical products.
An appendix to the notice shows the agency’s current definition of a medical device as
- Any article, instrument, apparatus or contrivance, including any component, part or accessory thereof, manufactured, sold or represented for use in (a) the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or its symptoms, in human beings or animals, (b) restoring, correcting or modifying a body function or the body structure of human beings or animals, (c) the diagnosis of pregnancy in human beings or animals, or (d) 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.
The agency did not name an expect-by date for the new guidance.
Coincidentally or not, the announcement of the project came just two weeks after the New England Journal of Medicine published a study showing Health Canada lagging behind the FDA and the European Medicines Agency in median review times for new drugs looked at between 2001 and 2010. Over that period, Health Canada trailed FDA in mean total review times by 71 days.