Near Vision Reading Cards in Canada vs the US: Which Rules Apply?

Quick facts

• A near vision reading card is a printed card held at a fixed short distance to measure reading acuity, usually at 40 centimetres or the practice's chosen working distance.
• United States: a visual acuity chart is a named device, 21 CFR 886.1150, Class I. The same section also carries the digital acuity test entry, so a paper card and a screen sit in one class.
• Canada: there is no chart entry. A printed card is a non-invasive device and falls to Class I under Rule 7(1) of Schedule 1 to the Medical Devices Regulations, SOR/98-282.
• The subtle Canadian question is whether a card is a tester. Rule 7(2)(a) lifts a device to Class II when it is intended to act as a calibrator, tester or quality control support to another medical device. A card that tests a patient does not fall into that clause.
• A card is not an instrument. It carries no calibration and no power supply, which is why it is bought as consumable stock rather than as equipment.
• The purchase test is the size notation, the contrast and the working distance printed on the card, all three of which differ between suppliers.

A near vision reading card looks like printing. It is a device, and the reason it is one is the same reason a distance chart is one: it substitutes a printed standard for an examiner's judgement. This article covers what a near card does, how each country classifies it, how the Canadian rule path differs from the United States entry, which card formats exist, what a practice should keep on hand, and what to record.

What is a near vision reading card, and what does it measure?

A near vision reading card carries rows of text, numerals or symbols in graduated sizes. The patient holds the card, or the examiner holds it, at a fixed distance and reads down the rows until the print can no longer be resolved. The result is recorded as a notation, not as a fraction. That notation is where most of the confusion in this purchase begins.

Three variables decide what a card actually measures:

• Reading distance. A card designed for 40 centimetres gives a different result when it is used at 30. The distance has to be printed on the card and held constant.
• Size notation. Metric, point size and printer's notation are three different scales. A card that does not state which scale it uses cannot be compared with another card.
• Contrast. A high-contrast black-on-white card and a low-contrast card measure different things, and a practice that uses both has to keep them apart.

21 CFR 886.1150 describes the family in one sentence: "a chart, such as a Snellen chart with block letters or other symbols in graduated sizes, intended to test visual acuity". The near card is the short-distance member of that family, and the entry is written to cover the family rather than one chart.

Do Canada and the United States classify a near vision card the same way?

The class comes out the same. The route does not, and the route is what a supplier has to be able to describe.

Item	Canada	United States
Named entry for a near vision card	None; class derived by rule	21 CFR 886.1150, visual acuity chart, Class I
Digital acuity test	No separate entry	Same section; digital visual acuity test, Class I
Class for a printed card	Class I under Rule 7(1)	Class I (general controls)
Rule that could lift the class	Rule 7(2)(a), if the article is a calibrator, tester or quality control support to another device	None of this shape
Premarket position	Licence only where the derived class requires one	Exempt from premarket notification, subject to § 886.9
Trial lens set and trial frame beside it	Class derived by rule	21 CFR 886.1405 and 886.1415, both Class I
Who holds the licence or registration	Manufacturer, importer or distributor	Manufacturer or repackager

The United States entry is broader than a reader might expect. Beyond the visual acuity chart itself, the same section carries a digital visual acuity test in Class I. A practice that has moved part of its lane onto a tablet therefore holds two products that answer to one section, and both are exempt from premarket notification subject to the limitations in the section.

Canada arrives at Class I by the fallback rule. Rule 7(1) sends "all other non-invasive devices" to Class I, and a printed card is non-invasive and otherwise unclassified. The next subrule is the one worth understanding, because it is the clause a supplier might misread: Rule 7(2)(a) raises a device to Class II when it "is intended to act as a calibrator, tester or quality control support to another medical device". A near card tests the patient's vision; it does not test a device. It stays in Class I.

Which standard fixes the optotype, and how do the two countries differ in applying it?

Both countries classify the card, and neither country's classification rule fixes the print. The print is a standards question, and the two systems answer it in the same place: through the instrument standard rather than through the device regulation.

• Instrument standards govern the physical article. ISO 15004-1:2020 sets general requirements for ophthalmic instruments, and it is the document a buyer can point to when asking a supplier whether a card and a lane light are compatible.
• Device rules govern the class. The United States section and the Canadian Schedule 1 rule each place the card, and nothing in either text specifies the letter size, the contrast or the working distance.
• The notation is a convention, not a standard. The reading-add notation used on near cards is a shorthand for a lens power that brings a chosen working distance into focus. Two cards can print the same notation at different distances, which is why the distance line matters.

This is the practical difference between the two countries for this product: the United States asks a supplier to show that the card sits inside a Class I entry with its exemption conditions met, while a Canadian buyer should ask the intended-use question directly, because the class is derived and the intended use is the input.

Which card formats exist, and which does a lane need?

Five formats cover the work in most lanes. Each answers a different question, and a lane that stocks all five without labelling them will mix results between visits.

Format	What it tests	What has to be printed on it
Near text card	Reading acuity at a stated short distance	Working distance, size notation
Illiterate or symbol card	Reading acuity where letters are not readable	Symbol system, distance, notation
Low-contrast card	Acuity under reduced contrast	Contrast level, distance
Reading ruler or card with line mark	Sustained reading and tracking	Line marker, distance
Digital acuity display	Acuity with variable optotype presentation	Calibration record, distance, software version

Two of these have consequences beyond the shelf. A low-contrast card is a different test from a high-contrast card, so the record has to name which one was used. A digital display is a device that is not the same article as a printed card, and a practice that relies on one should keep the calibration record with it.

What should a practice record?

A near vision reading is only comparable over time if the measurement conditions are recorded with the result. Four fields do that work:

• The card identity. Format and, where the practice holds several, the card reference.
• The working distance used. Recorded explicitly, because a change in distance changes the result.
• The contrast and lighting conditions. A card read under a lane lamp and a card read under room light are two measurements.
• The result notation, with its scale named. A number without a scale cannot be compared with a reading taken on another card.

Which consumables does an optical lane go through?

A near card is a consumable in a lane that also restocks table paper, swabs, tape, dressings, gloves and surface disinfectant. For practices buying at case level, the wholesale ordering page sets out account and case pricing, and the B2B wholesale collection lists the lines held for institutional buyers. The graphene USB heated eye mask is the warm compress line we hold for lid care, and lanes that also run an in-house sterilizer can begin with the biological indicator 5-pack trial and read the sterilization monitoring collection for the monitoring lines.

Sources

1. 21 CFR 886.1150, visual acuity chart
2. 21 CFR 886.1405, ophthalmic trial lens set
3. 21 CFR 886.1415, ophthalmic trial frame
4. Medical Devices Regulations, SOR/98-282, full text, Schedule 1
5. ISO 15004-1:2020, ophthalmic instruments, general requirements
6. Health Canada, medical devices
7. openFDA device classification database
8. FDA device classification database search
9. College of Optometrists of Ontario, standards of practice
10. Opto, Canadian Association of Optometrists eye health library
11. American Academy of Ophthalmology, eye health
12. American Optometric Association, healthy eyes
13. Canadian Ophthalmological Society
14. National Eye Institute, eye health information
15. World Health Organization, blindness and visual impairment
16. Public Health Ontario, infectious diseases
17. CCOHS, osh answers
18. Ontario, what OHIP covers
19. HealthyChildren.org, eye conditions and vision, American Academy of Pediatrics
20. Clinical and Laboratory Standards Institute

Related reading

• Eye chart in Canada vs the US: which optotype standard
• Snellen chart and eye test charts in Canada vs the US: which scale
• Comprehensive eye check-up in Canada vs the US: which exam interval
• Eye clinic consumables: gloves, swabs and tape for optometry

CliniEco Medical supplies eye care, laboratory and clinic consumables of the kind described in this article. Health Canada MDEL #35334. This article is written for clinic, procurement and eye care professionals and is not clinical guidance; test selection and the interpretation of a near vision result belong to the treating optometrist or physician.

Frequently Asked Questions

Is a near vision reading card a medical device?

Yes, in both countries. It carries a graduated printed standard used to test visual acuity, so it is a device rather than stationery. In the United States it falls inside 21 CFR 886.1150 in Class I; in Canada it is a non-invasive device classified by rule.

Which Canadian rule places a printed card in Class I?

Rule 7(1) of Schedule 1 to the Medical Devices Regulations, which classifies all other non-invasive devices as Class I. Rule 7(2)(a) would raise the class to Class II only where the device is intended to act as a calibrator, tester or quality control support to another medical device, which a patient-facing card is not.

Does the United States have a separate entry for a digital acuity test?

No separate section. The digital visual acuity test sits in the same Class I section as the printed chart, 21 CFR 886.1150, and both are exempt from premarket notification subject to the limitations in that section.

What has to be printed on a near vision card?

The working distance it is designed for, the size notation it uses and, where contrast is a variable, the contrast level. A card that omits the distance cannot be compared with a card that states one.

Does either country's rule specify the letter size on the card?

No. The device rules place the card in a class and do not set print sizes. Physical and optical requirements are a standards question, and ISO 15004-1 is the general instrument standard a buyer can point a supplier to.

How should a practice record a near vision result?

With the card identity, the working distance, the lighting and contrast conditions, and the result notation with its scale named. Without those four fields, two readings from the same patient on different days cannot be compared.