Quick facts
- A cold compress applied to the eye after a procedure is a non-invasive device that removes heat from the surface it touches. Nothing about it penetrates the body.
- United States: the code splits cold packs by mechanism, not by body site. A reusable gel pack sits in 21 CFR 890.5700 as Class I; a single-use chemical pack sits in 21 CFR 890.5710 as Class I; and a water-circulating pack sits in 21 CFR 890.5720 as Class II.
- The disposable pack has a carve-out. The premarket exemption in 890.5710 does not apply when the pack is intended for use on infants.
- Canada: there is no named pack entry in Schedule 1 to the Medical Devices Regulations, SOR/98-282. A non-invasive pack falls under Rule 7(1) as Class I, Rule 4(1) lifts it to Class II if it contacts injured skin, and Rule 4(2) returns it to Class I when it is acting as a barrier, for compression or to absorb exudations.
- A powered circulating unit is an active device in Canada and is classified under the active-device rules rather than the non-invasive rules.
- Canadian regulation text used here is current to 2026-09-21 and last amended 2026-06-17, as stated on the official consolidation.
A cold compress is one of the few items in an eye care setting that a patient may also buy at a pharmacy, which is why the classification question matters more than it first appears. The device is simple, but the two countries divide it along different axes: the American code divides by what generates the cold, and the Canadian rules divide by what the device touches and whether the device is active. This article sets out both routes, the pack types that fall under each, and the record a practice should keep.
What is a cold pack in each classification system?
The American code writes the identification paragraph around the physical construction, and the wording is worth reading because it fixes which packs are covered.
Section 890.5700(a) describes a cold pack as a device intended for medical purposes that consists of a compact fabric envelope containing a specially hydrated pliable silicate gel capable of forming to the contour of the body and that provides cold therapy for body surfaces. Section 890.5710(a) describes a hot or cold disposable pack as a device intended for medical purposes that consists of a sealed plastic bag incorporating chemicals that, upon activation, provides hot or cold therapy for body surfaces.
Two constructions, two sections. A reusable gel pack and a single-use chemical pack are treated as different generic types even though a clinician reaches for either one to do the same job.
Canada does not write a construction-based identification for the pack at all. The Regulations classify by whether the device is invasive, active, or neither. A cold pack applied to intact skin is none of the first two, so the non-invasive rules apply.
| Term | Definition as written in the Regulations |
|---|---|
| Invasive device | A medical device intended to come into contact with the surface of the eye or to penetrate the body, through a body orifice or through the body surface |
| Active device | A medical device that depends for its operation on a source of energy other than energy generated by the human body or gravity |
| Not an active device | A device that transmits or withdraws energy or a substance to or from a patient without substantially altering the energy or the substance |
| Non-invasive device | Everything that is neither invasive nor active |
That last definition is doing quiet work here. A gel pack pulled from a freezer transmits cold to the patient without altering the energy it carries, so it is not an active device in the Canadian sense. A powered unit that circulates chilled water through a pad has to be considered under the active-device rules instead.
How does a cold pack differ between Canada and the United States?
| Item | Canada | United States |
|---|---|---|
| Named entry for the pack | None in Schedule 1 | Separate sections by construction |
| Reusable gel pack | Rule 7(1), Class I | 890.5700, Class I |
| Single-use chemical pack | Rule 7(1), Class I | 890.5710, Class I |
| Water-circulating pack | Active-device rules if the unit is powered | 890.5720, Class II |
| Premarket notification | No exemption list, because there is no named entry | Exempt subject to 21 CFR 890.9, except a disposable pack intended for use on infants |
| Where the class can move | Rule 4(1) to Class II on injured skin; active-device rules for a powered unit | Not within the sections; a different mechanism points to a different section |
| Class of a powered circulating unit | Rule 9(1), Class II as an active therapeutic device | 890.5720, Class II |
The table shows the shape of the difference. An American buyer distinguishes packs by mechanism and lands on a section; a Canadian buyer distinguishes packs by contact and by whether the device is active, and lands on a rule. The class comes out the same for the pack a clinic actually uses, but the reason differs, and the reason is what a supplier has to be able to state.
Why does the disposable pack carry an infant carve-out?
Because the exemption in 890.5710 is drafted with a limitation that the reusable pack does not carry.
The reusable gel pack in 890.5700 is exempt from premarket notification without a stated exception, and it is also exempt from the quality system regulation in part 820 with the exception of the record-keeping requirements in 820.180 and the complaint file requirements in 820.198.
The disposable pack in 890.5710 is exempt from premarket notification subject to section 890.9, and the sentence is written with a carve-out: except when intended for use on infants. A single-use chemical pack marketed for use on an infant is therefore outside the exemption and the maker has to be able to show the device's premarket position.
For an eye care practice that is a labelling question rather than a clinical one, but it is the kind of question that surfaces when a supplier substitutes one pack for another. A pack that was exempt for adult use does not carry the same exemption statement when the intended use names a newborn.
When does an eye cold compress change class in Canada?
Three situations move the device, and each moves it for a different reason.
The first is contact with injured skin. Rule 4(1) classifies a non-invasive device intended to come into contact with injured skin as Class II. A pack laid over intact periocular skin is outside that subrule; a pack laid over a fresh wound is inside it.
The second is the barrier exception. Rule 4(2) returns a device to Class I when it is intended to be used as a mechanical barrier, for compression or for absorption of exudations. That subrule is drafted to keep simple dressings in Class I, and a pack that is also acting as compression sits there rather than in Rule 4(1).
The third is power. A unit that circulates chilled water through a pad is an active device, because it depends on a source of energy and it alters the thermal energy it delivers rather than merely transmitting it. Rule 9(1) classifies an active therapeutic device intended to administer or withdraw energy to or from the body as Class II, and Rule 9(2) raises the class to Class III where the administration or withdrawal is potentially hazardous, taking into account the nature of the administration, the intensity of the energy and the part of the body concerned.
That last sentence is the one to hold on to for anything used on the eye. The rule itself names the intensity of the energy and the part of the body as the factors, and the eye is a part of the body where intensity matters.
What should a practice record for cold therapy supplies?
Five items, all of them supplied by the maker rather than generated by the practice.
- The mechanism. Chemical single-use, reusable gel, or powered circulation. On the American side this is what selects the section.
- The stated contact surface. Intact skin or a wound, because that is what selects between Rule 4(1) and Rule 4(2) in Canada.
- The temperature and duration instruction. From the maker's directions for use, kept with the device record rather than retyped.
- The barrier used between pack and skin. A single-use barrier changes what the pack touches, and that belongs in the record with the pack.
- The premarket position. For a disposable pack, whether the maker's labelling restricts the device to adult use, since the exemption statement turns on that.
Which consumables does an eye clinic restock alongside its cold therapy supplies?
An eye care practice restocks barriers, paper, drapes and cleaning supplies on the same cycle as its instruments. For practices buying at case level, the wholesale ordering page sets out account and case terms, and the B2B wholesale collection lists the lines held for institutional buyers. The reusable moist heat eye compress covers the compress format used in a lid hygiene routine, the exam table paper roll covers the couch between patients, and a practice that wants the monitoring and consumable lines together can start with the sterilization monitoring collection or the biological indicator 5-pack trial.
Sources
- 21 CFR 890.5700, cold pack
- 21 CFR 890.5710, hot or cold disposable pack
- 21 CFR 890.5720, hot or cold water circulating pack
- 21 CFR 890.9, limitations of exemptions
- 21 CFR 886.4750, ophthalmic eye shield
- Medical Devices Regulations, SOR/98-282, full text and Schedule 1
- openFDA device classification API
- FDA device classification database
- ISO 10993-1:2018, biological evaluation of medical devices
- ISO 8596:2017, visual acuity testing, optotypes
- College of Optometrists of Ontario, standards of practice
- Canadian Association of Optometrists, eye health library
- World Health Organization, blindness and visual impairment
- Canadian Centre for Occupational Health and Safety, OSH answers
- Canadian Centre for Occupational Health and Safety, personal protective equipment
- Public Health Ontario, infectious diseases
- US OSHA bloodborne pathogens standard, 1910.1030
- Health Canada, medical devices
- ISO 11138-1:2017, biological indicators
- Public Health Ontario, laboratory services test information index
Related reading
- Eye Wash Solution in Canada vs the US: Which Flushing Fluid Rules Apply
- Eye Shields in Canada vs the US: Which Device Rules Apply
- Newborn Eye Tests in Canada vs the US: Which Red Reflex Rules Apply
CliniEco Medical supplies eye care, laboratory and clinic consumables of the kind described in this article. MDEL #35334. This article is written for clinic, procurement and infection-control professionals and is not clinical guidance; the use of cold therapy after a procedure, its duration and its suitability for a given patient belong to the treating professional and to the provincial requirements that apply to the practice.
Frequently Asked Questions
What class is a reusable cold gel pack in the United States?
Class I, general controls, under 21 CFR 890.5700. The section describes the device as a compact fabric envelope containing a hydrated pliable silicate gel that forms to the contour of the body, exempts it from premarket notification, and exempts it from the quality system regulation except for the record-keeping requirements in 820.180 and the complaint file requirements in 820.198.
What class is a single-use chemical cold pack in the United States?
Class I under 21 CFR 890.5710, exempt from premarket notification subject to 21 CFR 890.9, except when the pack is intended for use on infants. A pack marketed for infant use is outside that exemption statement.
Does Canada have a named entry for a cold pack?
No. Schedule 1 to the Medical Devices Regulations classifies by rule. A cold pack applied to intact skin is a non-invasive device and falls under Rule 7(1) as Class I. Contact with injured skin moves it to Class II under Rule 4(1), and the barrier exception in Rule 4(2) returns a compression or absorbent pack to Class I.
How does Canada classify a powered cold therapy unit?
As an active device, because it depends on a source of energy and alters the thermal energy it delivers. Rule 9(1) classifies an active therapeutic device intended to administer or withdraw energy to or from the body as Class II, and Rule 9(2) raises it to Class III where the administration or withdrawal is potentially hazardous, taking into account the intensity of the energy and the part of the body concerned.
Is a cold compress on the eye different from a cold pack on the knee?
Not in the classification. Nothing about a cold pack turns on the body site in either code. What turns on the site is the advisory content around the device, because the eye tolerates applied cold differently from a limb, and that guidance belongs with the treating professional.
What should a practice keep on file for cold therapy supplies?
The mechanism of the pack, the stated contact surface, the temperature and duration instruction from the maker, the barrier used between pack and skin, and for a disposable pack the premarket position shown on the maker's labelling. The mechanism selects the American section and the contact surface selects the Canadian rule.
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