Infant Vision Charts in Canada vs the US: Which Tests Apply?

7 octobre 2026

Sterile folded gauze sponges packed for clinical and paediatric use

Quick facts

An infant cannot read a letter chart, so screening uses the red reflex, fixation and following, preferential looking and optokinetic nystagmus instead.
A vision chart used with an older child is a Class I entry in the United States, 21 CFR 886.1150; an optokinetic drum used with an infant is a separate Class I entry, 21 CFR 886.1200.
In Canada a non-invasive vision aid of this kind is a Class I device under Rule 7(1) of the Medical Devices Regulations.
The test method is set by clinical guidance rather than by the device class: the Canadian Paediatric Society and the American Academy of Pediatrics publish the screening steps, not the rulebooks.
A chart that works for a four-year-old, such as a Lea symbol card, does not work for an infant; the age of the child decides the aid, not the shelf.
The entries and rule text quoted here were checked against the openFDA device classification API and the Regulations on 2026-10-06.

An infant vision chart is a printed or projected target — a card, a drum or a graded set of patterns — that a clinician uses to estimate how well a baby can see before the child can name or match letters. It is used in the newborn check, at the well-baby visit and in a paediatric eye clinic. The reason a clinic keeps more than one aid is that the test has to match the age of the child.

Why can an infant not use a letter chart?

Because the test relies on a response the child can give. A Snellen chart needs the child to name or match letters, which a baby cannot do. So the clinician looks for responses a baby does give: a red reflex seen through an ophthalmoscope, fixation on a light or face, following a target across the midline, and the optokinetic response a moving striped drum produces. Each of these is a screening step, and each has its own aid.

That is the part that catches a new buyer out. The shelf label says "vision chart", but a graded set of cards, a rotating drum and a symbol chart are three different products used at three different ages. A room stocked with only a symbol chart will have nothing to use on a six-month-old.

How do Canada and the United States classify the aids used?

The two countries reach the same class for these aids, from different rules.

Aid	Canada	United States
Letter or symbol chart	Class I, non-invasive device	Class I, 21 CFR 886.1150
Optokinetic drum	Class I	Class I, 21 CFR 886.1200
Bar prism	Class I	Class I, 21 CFR 886.1650
Ophthalmoscope	Class II instrument	Class entry for the diagnostic device
Basis of class	Whether the aid is invasive	The named entry it is filed under

In the United States each aid is a named Class I entry, and a product filed under that entry reaches the market without premarket notification where the entry is exempt. In Canada the aids are non-invasive devices, so Rule 7(1) of the Regulations places them in Class I. A Class I device is not licensed device by device; the manufacturer keeps an establishment licence and the records the Regulations require.

The distinction that moves real work is between the chart and the instrument. A printed card is a low-risk aid, while an ophthalmoscope used to see the red reflex is a diagnostic instrument with its own class. A clinic buying both is buying two device categories, not one kit.

What does each screening step test for?

The steps build on each other, and each one rules out a different problem.

Age	Step	What it looks for
Newborn	Red reflex	A clouded reflex from a cataract or a tumour
6 to 12 months	Fixation and following	Whether each eye fixes and holds a target
12 to 24 months	Preferential looking	Whether the child prefers a patterned target to a blank one
2 to 4 years	Symbol matching chart	Acuity in a child who can match but not read
From about 4 years	Letter chart	Standard acuity in the notation the clinic uses

Read together, the five lines show why the aid changes with age. A test that asks too much of the child produces a result that looks normal because the child simply did not respond, and a test that asks too little misses the defect it was meant to find.

Which standard covers the instrument itself?

The aids are simple, but the instruments around them are not, and that is where a standard applies. ISO 15004-1 sets general requirements for ophthalmic instruments, and ISO 13485 sets the quality-system requirement a manufacturer has to hold for a licensed device. A clinic that services its own instruments should keep the service record with the aid that depends on it.

For a practice the practical step is to keep the screening protocol and the aids together, and to state which aid is used at which age. That single pairing removes the confusion a locum brings to a room where the chart is the only aid on the wall.

What do the two rulebooks actually say?

The two texts are short, and the difference between them is the point of this article.

Rule or entry	Wording in the source	Effect on an infant screening aid
21 CFR 886.1150, US	Chart, visual acuity	Named Class I entry
21 CFR 886.1200, US	Drum, optokinetic	Named Class I entry
21 CFR 886.1650, US	Prism, bar, ophthalmic	Named Class I entry
Rule 7(1), Canada	all other non-invasive devices are classified as Class I	Class I aid
Rule 2(1), Canada	come into contact with the surface of the eye … Class II	Applies only to a contact device

Read together, the five lines explain why a supplier cannot move the class by relabelling a card as an instrument. A card described as non-invasive while it is held in front of a child is described against the text, not against the shelf.

Which consumables does a paediatric eye room restock?

A paediatric room runs on the same bench supplies as any other room. The smooth white exam table paper covers the bench between children, and the double-tipped cotton swabs handle the routine wipe-down of an instrument head. A practice that also monitors its own steriliser pairs the sterilization monitoring collection 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.

Cotton swabs on a preparation bench used for surface and dilution sampling

What does a paediatric vision record need?

A screening record is only useful if it says which step was used and what the child did. The useful fields are the age, the aid used, whether each eye fixed and followed, and the outcome, because a result without the aid cannot be repeated by the next clinician. A record that says "vision normal" without the step is a note rather than a result.

The second field that matters is the follow-up. A child who could not be tested, or whose result was borderline, needs a date for a repeat rather than a closed line. That one field turns a screening visit into a programme, and it is the field a locum asks for first when a child returns to the room.

Sources

A count of how many children are screened is a count that is hard to rebuild later. The printable paediatric screening log is a blank form with columns for the age, the step used and the outcome, so a child who needs a repeat test is visible on the day. The screening log generator on the same page sizes the form to the number of clinics a service runs. No account and no sign-up are needed to open either one.

Every paediatric setup 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

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

Can an infant be screened with a Snellen chart?

No. A Snellen chart needs the child to name or match letters. An infant is screened with the red reflex, fixation and following, preferential looking and the optokinetic response instead.

Is a vision chart a Class I device in the United States?

Yes. A visual acuity chart is a named Class I entry at 21 CFR 886.1150, and an optokinetic drum is a separate Class I entry at 21 CFR 886.1200.

How does Canada classify the same aids?

In Canada these aids are non-invasive devices, and Rule 7(1) of the Medical Devices Regulations places all other non-invasive devices in Class I. An aid that contacts the surface of the eye is treated differently.

Which test is used at which age?

The red reflex is used in the newborn period, fixation and following from about six months, preferential looking from about twelve months, a symbol matching chart from two to four years, and a letter chart from about four years.

Does the device class set the screening protocol?

No. The class decides whether the aid can be sold. The screening steps are set by clinical guidance, such as that published by the Canadian Paediatric Society and the American Academy of Pediatrics.

Why keep more than one chart in a room?

Because a chart that suits a four-year-old does not suit a baby. A room that stocks only a symbol chart has nothing to use on an infant, so the screening stops rather than moving to the correct aid.

What does the class change for a supplier?

In Canada a Class I device sits under an establishment licence and records rather than a device licence, while a Class II device needs a licence under section 32 supported by an ISO 13485 certificate. In the United States a Class I entry reaches the market without premarket notification where the entry is exempt.