Quick facts
- A visual acuity chart is a named Class I device in the United States at 21 CFR 886.1150.
- A digital visual acuity test is filed under the same number, 886.1150, in the United States.
- Canada names no acuity chart: a chart or a screen is a non-invasive device and reaches Class I through Rule 7(1) of the Medical Devices Regulations.
- A chart that is connected to an active device in a higher class moves up with it under Rule 7(2)(b).
- Screening ages differ by country: the American guidance and the Canadian position statement do not set the same schedule.
- The regulation text cited here is current to 2026-09-21 and was last amended on 2026-06-17.
A vision screen in a child is not the same test as a full eye examination in an adult. It is a short, age-appropriate check that sorts children who need a full assessment from those who do not. What the clinician holds to run that check — a chart, a card, a handheld screen — sits in a very different place in the two national rulebooks.
What is pediatric vision screening?
It is a brief test that looks for a reduced ability to see clearly, or for the signs that usually go with it, in a child who is not yet old enough to report it.
The test changes with age. A pre-verbal child cannot read letters, so the screen uses a shape, a picture, a grating or a light reflex. A school-age child can be tested with a letter chart or with a matching card. What stays constant is the purpose: to find a child who needs a referral to an optometrist or an ophthalmologist, not to make the diagnosis inside the screening room.
That is why the device list is wider than a single chart. A wall chart, a handheld card set, a matching card or a portable screening unit all do the same job at different ages, and each one is a medical device that has to be classified before it can be sold.
How do Canada and the United States classify a vision screening chart?
The chart lands in Class I on both sides of the border, but by a different path.
| Item | Canada | United States |
|---|---|---|
| Visual acuity chart | Class I by Rule 7(1) | Class I, 21 CFR 886.1150 |
| Digital acuity test | Class I by Rule 7(1) | Class I, 21 CFR 886.1150 |
| Colour vision tester | Class I by Rule 7(1) | Class I, 21 CFR 886.1170 |
| Colour plate illuminator | Class I by Rule 7(1) | Class I, 21 CFR 886.1160 |
| Basis named in the rulebook | Rule and use | Device entry and product code |
In the United States the acuity chart is a named entry (21 CFR 886.1150), and a digital acuity test is filed under the same number. A colour vision tester is named separately at 21 CFR 886.1170, and the colour plate illuminator at 21 CFR 886.1160. Each is Class I.
In Canada none of these is a named entry. A chart is a non-invasive device, and Rule 7(1) places all other non-invasive devices in Class I. The class is the same; the route is not. A file that cites the rule and the intended use is complete in Canada, where a US file cites the device entry.
At what ages does screening differ between Canada and the United States?
The device is the same; the schedule is not, because each country sets its own guidance rather than one shared requirement.
In the United States vision screening is built into well-child care, and the professional bodies publish an age schedule that pairs a type of test with each stage. In Canada the Canadian Paediatric Society publishes a position statement on vision screening in infants, children and youth, and provincial programmes add their own entry points, often through public health or school screening. The two schedules overlap but are not identical, which matters to a clinician who compares a US worksheet with a Canadian pathway.
For a supplier the consequence is concrete. A clinic that runs a school-age screen needs the chart and the matching card that fit the age group the programme actually sees. A clinic that screens preschool children needs the test that works before a child can name letters. The right product is set by the age the programme covers, and the age is set by the province or the state.
Why does a screening unit change class when a chart does not?
Because the class follows what the device is connected to, not the fact that both are sold as screening tools.
A paper chart is a sheet. It emits nothing and it connects to nothing, so it stays where Rule 7(1) puts it. A screening unit that contains a powered component, or that links to an active device in a higher class, is read by Rule 7(2)(b): a non-invasive device connected to an active device that is Class II, III or IV takes the class of that device. A screen that reports a result through a Class II device is therefore not a Class I sheet.
This is the point most often missed when a clinic buys a screening cart as a package. The chart on the cart is Class I in its own right. The cart is not. Reading the class from the chart and applying it to the whole station is how the gap opens.
Which consumables does a pediatric vision clinic restock?
A screening room runs on the same bench supplies as any other examination room. The sterile graduated 90 mL specimen cups carry samples to the bench, and the 120 mL sterile screw-cap container holds anything that has to be kept before processing. Where a clinic also runs its own sterilisation cycle, the sterilization monitoring collection pairs with the 24-hour monitoring five-pack trial. Clinics and multi-site groups ordering at case level use the wholesale ordering page, and the B2B wholesale collection lists the lines held for institutional buyers. Reselling? become a distributor.
Which charts and tests fit each age band?
The test is chosen by what the child can do, not by what the clinic happens to own.
| Age band | What the child can do | Test that fits | Device route (Canada / US) |
|---|---|---|---|
| Infant and pre-verbal | Fixate and follow | Grating, picture or photo screen | Rule 7(1) / 886.1150 |
| Preschool | Match a shape or a picture | Matching card, Lea symbols, tumbling E | Rule 7(1) / 886.1150 |
| School age | Name a letter | Letter chart, logMAR chart | Rule 7(1) / 886.1150 |
| Any age, colour check | Match plates | Colour vision tester and plate illuminator | Rule 7(1) / 886.1170 and 886.1160 |
A screen that uses the wrong test for the age band produces a result that cannot be acted on. A three-year-old who is handed a letter chart will fail it for reasons that have nothing to do with vision, and the referral that follows records a condition the child does not have. Matching the test to the age is the difference between a screen that finds the children who need help and one that generates work for the referral pathway without finding anyone.
The device route is the same for every row: on the Canadian side each chart, card and tester is a non-invasive device that reaches Class I by Rule 7(1), and on the US side each is a named entry at 21 CFR 886.1150 for acuity and 21 CFR 886.1170 for colour vision, with the plate illuminator at 21 CFR 886.1160. A clinic that stocks the full range is holding several US entries and one Canadian rule.
Sources
- 21 CFR 886.1150, visual acuity chart
- 21 CFR 886.1170, colour vision tester
- 21 CFR 886.1160, colour vision plate illuminator
- 21 CFR 886.1510, eye movement monitor
- 21 CFR 886.4750, eye shield, ophthalmic
- Medical Devices Regulations, SOR/98-282
- Canadian Paediatric Society, documents
- Opto, eye health library
- College of Optometrists of Ontario, standards of practice
- American Academy of Ophthalmology, eye health
- Public Health Ontario, laboratory services test index
- CCOHS, OSH answers
- ISO 15189:2022, medical laboratories
- ISO 13485:2016, quality management
- ISO 14971:2019, risk management
- CLSI, clinical and laboratory standards
- Canadian Dental Association
- Royal College of Dental Surgeons of Ontario
- ADA, science and research institute
- openFDA device classification API
A screen that is not written down is a screen that cannot be followed up. The printable vision screening log is a free sheet with columns for the child, the age, the test used, the result and the referral, so a repeat screen is planned rather than remembered. The screening record generator on the same page sizes the sheet to the number of rooms and the age bands a clinic runs. No account and no sign-up are needed to open either one.
Every equipment layout is different. Ask a compliance specialist and you will get a written answer specific to your equipment and province, with the regulation or standard it is based on cited.
Related reading
- Eye Shields in Canada vs the US: Which Device Rules Apply?
- Colour Vision Test Charts in Canada vs the US: Which Rules Apply?
- Comprehensive Eye Check-Up in Canada vs the US: Which Exam Interval Applies?
CliniEco Medical supplies eye care, laboratory 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 a device and the records kept by a clinic belong to the manufacturer and to the requirements that apply to it.
Frequently Asked Questions
Is a visual acuity chart a Class I device in the United States?
Yes. A visual acuity chart is Class I under 21 CFR 886.1150, and a digital visual acuity test is filed under the same number.
Does Canada name a visual acuity chart?
No. The Canadian schedule names few devices, and a chart is not one of them. A chart is a non-invasive device, and Rule 7(1) of the Medical Devices Regulations places all other non-invasive devices in Class I.
What changes the class of a screening unit?
In Canada a non-invasive device connected to an active device that is Class II, III or IV takes the class of that device under Rule 7(2)(b). A paper chart emits nothing and connects to nothing, so it stays Class I; a powered screening unit that reports through a higher-class device does not.
Do Canada and the United States screen children at the same ages?
No. The United States pairs vision screening with well-child care on a published age schedule, and Canada relies on the Canadian Paediatric Society position statement plus provincial programmes with their own entry points. The two overlap but are not identical.
Why does the age matter to a supplier?
Because the test changes with age. A pre-verbal child is screened with a shape, a picture or a photo screen, and a school-age child can be screened with a letter chart or a matching card. The age band a programme covers decides which products a clinic actually needs.
What should a screening record carry?
The child, the age, the test used, the result and whether a referral was made. The record is what turns a single screen into a follow-up plan.
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