Quick facts
- United States: a device that records eye movement for a clinical purpose is a named entry — 21 CFR 886.1510, eye movement monitor — and sits in Class II.
- United States: the entry is divided by product code rather than by class, with a recording monitor and a diagnostic monitor filed under separate codes, both Class II.
- Canada: there is no named eye-movement-monitor entry; the instrument is classified by rule, and Rule 10(1) puts an active diagnostic device that supplies energy for monitoring physiological processes in Class II.
- Canada: the same instrument rises to Class III under Rule 10(2) where an erroneous reading could result in immediate danger.
- Both countries: the monitor measures the eye; the surface under and around the head frame is cleaned between patients rather than reprocessed.
- Canada: the regulation text cited here is current to 2026-09-21 and was last amended on 2026-06-17.
An eye tracker produces the same trace whichever side of the border it runs on, but the two systems behind that trace read the instrument differently. One files it under a name and a code; the other decides a class from what the instrument is doing. For a clinic buyer, that split decides what the quotation cites, what the maintenance record carries, and what a reviewer will look for when the instrument is checked.
What makes an eye movement monitor a regulated device?
It is regulated because it records the position and motion of the eye for a clinical purpose, and both countries treat an instrument that does that as a medical device.
The difference is in how the instrument is described. In the United States the device is named directly: 21 CFR 886.1510 describes an eye movement monitor as a device intended to measure eye movement. In Canada the same instrument is not named in the classification schedule attached to the Medical Devices Regulations, SOR/98-282; its class comes from the active-device rules.
That difference is not cosmetic. A named American entry carries a product code that a listing is filed against, and that code is what a buyer checks when a written quotation is drawn up. A Canadian rule-based class carries no code — it carries the reason, and the reason is what a records review reads back.
| Item | Canada | United States |
|---|---|---|
| How the monitor is described | By rule, not by name | A named entry at 21 CFR 886.1510 |
| Class the instrument lands in | Class II under Rule 10(1) | Class II |
| What a filing cites | The rule and its subrule | The device entry and product code |
| What raises the class | An erroneous reading that could cause immediate danger (Rule 10(2)) | A change that leaves the entry |
How do Canada and the United States classify the same eye tracker?
The American route asks what the device is called; the Canadian route asks what the device does. The two reach the same class for a plain monitor and then separate as soon as the monitor is given a diagnostic job.
Rule 10(1) in Canada covers an active diagnostic device that supplies energy for the purpose of monitoring physiological processes. An eye movement monitor drives a stimulus and reads the response, which places it inside that subrule and in Class II. Rule 10(2) then lifts the class to Class III for a device intended to monitor, assess or diagnose a disease where an erroneous reading could result in immediate danger.
In the United States the 21 CFR 886.1510 entry carries no such escalation inside it. A monitor matching the description is Class II, and an instrument that has been changed so that it no longer matches would be assessed against a different path rather than against a subrule in the same section.
The practical reading for a clinic is that the Canadian class is a statement about use, while the American class is a statement about identity. A recording monitor and a diagnostic monitor can share one American entry and split across two Canadian subrules.
Do Canada and the United States split eye movement monitors by product code?
No, they split the instrument differently. The United States divides the entry by the role the monitor plays, while Canada uses no code at all and reaches a class from a rule.
An eye movement monitor in the American classification database is filed with more than one code. A monitor that records eye movement carries one code, and a monitor whose purpose is diagnostic carries another, both inside 21 CFR 886.1510 and both in Class II. The code separates a recording instrument from a diagnostic one without moving either out of the class.
What this means for a clinic is that the phrase "it only records" does not change the American class. The instrument is regulated as an eye movement monitor because that is the name it is given, and the class is fixed by that name.
| Monitor role | US product code | US class | Canadian basis | Canadian class |
|---|---|---|---|---|
| Records eye movement | HLL | Class II | Rule 10(1), active diagnostic monitoring | Class II |
| Diagnostic eye movement monitor | HMC | Class II | Rule 10(1), active diagnostic monitoring | Class II |
| Used where an error is immediately dangerous | Same entry | Class II | Rule 10(2), erroneous reading risk | Class III |
Does Canada name an eye movement monitor, or does a rule decide its class?
A rule decides it. The Canadian schedule names only a handful of devices outright and leaves the rest to the rules that precede the short table.
An eye movement monitor is one of the devices the rules settle. Rule 10(1) reaches it because the monitor is active and diagnostic and it supplies energy to monitor a physiological process. Rule 7, which catches other non-invasive devices, does not apply because an active device is dealt with by the active-device rules before the catch-all is reached.
The consequence is that a Canadian buyer cannot look the instrument up by name and read off a class. The buyer has to know what the monitor does, find the subrule that covers that description, and keep the subrule with the purchase record. When the same instrument is bought for two different clinical uses, the class has to be re-read for each use rather than copied from the last order.
When does an eye movement monitor become Class III in Canada?
It becomes Class III when the monitor is intended to monitor, assess or diagnose a condition where an erroneous reading could cause immediate danger. That is the situation Rule 10(2) was written for.
A monitor used to guide a procedure where a wrong reading is dangerous, or to reach a diagnosis where a missed finding leads to rapid harm, is inside that subrule. The same instrument used for a general recording task stays in Class II. A programme that adds the higher-risk use to an existing monitor is changing the classification premise of the device, not only its workload.
In the United States, a monitor used for the same task remains inside the named entry while it matches that description. A monitor with a claimed use outside the entry is assessed against whatever entry does describe it, which is a different mechanism from a subrule that escalates on risk.
Which consumables does an eye testing room restock?
A testing room runs on the same consumables as the rest of the practice, and the two closest to a head frame are the paper and the swab. The exam table paper covers the surface and is changed between patients, while the double-tipped cotton swabs handle the clean of the frame and the surface electrodes. A practice that also runs its own steriliser pairs the sterilization monitoring collection with the 24-hour monitoring five-pack trial. For clinics and multi-site groups 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. Reselling? become a distributor.
Sources
- 21 CFR 886.1510, eye movement monitor
- 21 CFR 886.1120, ophthalmic camera
- 21 CFR 886.1150, visual acuity chart
- 21 CFR 886.1330, Amsler grid
- 21 CFR 886.1760, ophthalmic refractometer
- 21 CFR 886.1850, AC-powered slitlamp biomicroscope
- 21 CFR 886.4750, ophthalmic eye shield
- Medical Devices Regulations, SOR/98-282
- ISO 15004-1:2020, ophthalmic instruments
- ISO 13485:2016, medical device quality management
- ISO 14971:2019, risk management of medical devices
- IEC 61010-1:2010, safety of electrical measuring equipment
- openFDA device classification API
- American Academy of Ophthalmology, eye health
- American Academy of Ophthalmology, pink eye
- College of Optometrists of Ontario, standards of practice
- Opto, eye health library
- CCOHS, OSH answers
- Public Health Ontario, laboratory services test index
- CLSI, clinical and laboratory standards
A testing room whose clean record is missing is a room that cannot answer a question about the last patient in the chair. The downloadable eye tracking room log is a free sheet with columns for the instrument, the clean-down, the operator and the date, so a surface clean is written down rather than remembered. The log sheet generator built for a single-lane practice sizes the sheet to the number of lanes a practice runs and the instruments in each. No account and no sign-up are needed to open either one.
Ordering testing-room consumables for a single chair or a group practice? See the wholesale ordering page.
Related reading
- Ophthalmoscopes in Canada vs the US: Which Device Class
- Tonometer Probes in Canada vs the US: Which Class
- Visual Field Screening in Canada vs the US: Which Perimeter Rules
CliniEco Medical supplies laboratory, eye care and dental consumables of the kind described in this article. MDEL #35334. This article is written for optometry, laboratory and procurement professionals and is not legal advice; the class of an instrument and the records kept by a practice belong to the practice and to the requirements that apply to it.
Frequently Asked Questions
Is an eye movement monitor a Class II device in the United States?
Yes. A device matching the eye movement monitor entry at 21 CFR 886.1510 is in Class II, whether it is filed under the recording code or the diagnostic code.
Does Canada have a named entry for an eye movement monitor?
No. The Canadian schedule names very few devices outright, and an eye movement monitor is not one of them. Its class is decided by the active-device rules, with Rule 10(1) placing a monitoring or imaging device in Class II.
When does an eye movement monitor become Class III in Canada?
When the monitor is intended to monitor, assess or diagnose a condition where an erroneous reading could cause immediate danger. Rule 10(2) escalates the class in that situation, so the intended use is part of the classification.
What is the difference between the two American product codes for this device?
One code covers a monitor that records eye movement and another covers a monitor whose purpose is diagnostic. Both sit in the same entry and in the same class; the code separates the role, not the class.
Why is the same eye tracker classified differently in the two countries?
The American system names the device and fixes a class to that name. The Canadian system describes what the device does and fixes a class to that description, so the same hardware can take a different class when its intended use changes.
Does an eye tracker need reprocessing between patients?
An instrument that does not enter the eye is not sterilised, but the head frame and the surface under it are cleaned between patients. Writing the clean-down, the operator and the date on one sheet is the record that answers a review.
0 commentaire