Product User Instructions Requirements in the United States: An Overview

User instructions are sometimes required for both consumer products and products used for commercial or industrial purposes. Even if user instructions are not mandatory, providing this information can reduce the risk of safety issues resulting in product recalls.

In this guide, we explain what importers and manufacturers must know about user instructions for various product categories – including children’s products, electronics, and protective equipment.

Which products require user instructions in the United States?

Certain products that are sold or used in the United States are required to come with user instructions. Here are some examples of products that may require user instructions:

• Children’s products
• Electronics
• Medical devices
• Batteries
• Personal protective equipment

For context, user instructions may include information on safe usage, proper assembly, maintenance, storage, and disposal.

Consumer Product Safety Improvement Act (CPSIA) – Toys and Children’s Products

The Consumer Product Safety Improvement Act (CPSIA) contains requirements for children’s products that are implemented by CPSC regulations which may contain user instruction requirements.

For instance, 16 CFR Part 1203 requires bicycle helmets, including children’s bicycle helmets, to come with fitting and positioning instructions.

Here are some other examples of children’s products that must come with instructions:

• Children’s bunk beds
• Children’s bicycles
• Electrically operated toys
• Toys

Here we list the information that should appear in the instructions for the products that we just mentioned.

Part 16 CFR Part 1203.6 requires bicycle helmets to come with fitting and positioning instructions. Additionally, it should come with a graphic representation of proper positioning.

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16 CFR Part 1203.6(b): Instructions. Each helmet shall have fitting and positioning instructions, including a graphic representation of proper positioning.

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Under 16 CFR Part 1513.6 on children’s bunk beds, the instructions must contain information on the size of the mattress and the foundation of the bunk bed. Additionally, it should also contain safety warnings provided in the regulation.

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16 CFR Part 1513.6: Safety warnings. The instructions shall provide the following safety warnings:

(1) Do not allow children under 6 years of age to use the upper bunk.

(2) Use guardrails on both sides of the upper bunk.

(3) Prohibit horseplay on or under beds.

(4) Prohibit more than one person on upper bunk.

(5) Use ladder for entering or leaving upper bunk.

(6) If the bunk bed will be placed next to a wall, the guardrail that runs the full length of the bed should be placed against the wall to prevent entrapment between the bed and the wall. (This applies only to bunk beds without two full-length guardrails.

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16 CFR Part 1512.19 requires bicycles to come with an instruction manual that covers content like assembly and maintenance instructions.

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16 CFR Part 1512.19: A bicycle shall have an instruction manual attached to its frame or included with the packaged unit.

(a) The instruction manual shall include at least the following:

(1) Operations and safety instructions describing operation of the brakes and gears, cautions concerning wet weather and night-time operation, and a guide for safe on-and-off road operation.

(2) Assembly instructions for accomplishing complete and proper assembly.

(3) Maintenance instructions for proper maintenance of brakes, control cables, bearing adjustments, wheel adjustments, lubrication, reflectors, tires and handlebar and seat adjustments; should the manufacturer determine that such maintenance is beyond the capability of the consumer, specifics regarding locations where such maintenance service can be obtained shall be included. […]

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Under 16 CFR Part 1505.3, electrically operated toys must come with instructions that are easily understood by children. The Part stipulates that content should be present in the instructions. For example, the instruction must describe the applicable installation and contain information on the proper maintenance of the toy.

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16 CFR Part 1505.3(b)(3): Each toy shall be provided with adequate instructions that are easily understood by children of those ages for which the toy is intended. The instructions shall describe the applicable installation, assembly, use, cleaning, maintenance (including lubrication), and other functions as appropriate. Applicable precautions shall be included as well as the information required by paragraphs (b) (1) and (2) of this section, except that the date of manufacture information described in paragraph (b)(1)(iii) of this section need not be included in the instructions provided with the toy if it is placed on the toy itself. The instructions shall also contain a statement addressed to parents recommending that the toy be periodically examined for potential hazards and that any potentially hazardous parts be repaired or replaced.

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16 CFR Part 1250 incorporates by reference ASTM F963 – Standard Consumer Safety Specification for Toy Safety which sets requirements for instructional literature and marking accompanying toys. Note that the ASTM page on the standard does not provide further details on the requirements.

47 CFR Part 15 – Electronics

The Federal Communications Commission (FCC) establishes the technical requirements for intentional, unintentional, and incidental radiators in the United States. 47 CFR Part 15 requires regulated products to bear user instructions that should specify information such as the following:

• Installation procedures
• How to access electronic displays
• Proper grounding techniques
• The use of shielded cables
• Components installation and use

Note that the required instructions may vary according to the characteristics of the product.

Here are some examples of products that may require instructions:

• Wrist watches
• Electrical coffee pots
• Wireless microphones
• Bluetooth radio devices

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47 CFR Part 15.21: The users manual or instruction manual for an intentional or unintentional radiator shall caution the user that changes or modifications not expressly approved by the party responsible for compliance could void the user’s authority to operate the equipment. In cases where the manual is provided only in a form other than paper, such as on a computer disk or over the Internet, the information required by this section may be included in the manual in that alternative form, provided the user can reasonably be expected to have the capability to access information in that form.

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The regulation also provides guidelines on the instructions that may be needed to install product accessories:

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47 CFR Part 15.27(a): […] The instruction manual for such devices shall include appropriate instructions on the first page of the text concerned with the installation of the device that these special accessories must be used with the device. […]

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UL Standards

Some UL standards also set requirements for instructions. For example, as outlined in this page, UL 4200A – Products Incorporating Button Batteries or Coin Cell Batteries requires battery-powered products to come with specific instructions for replaceable and non-replaceable button cells and coin batteries.

ASTM Standards

Some ASTM standards may also set instruction requirements. Here are some examples of ASTM standards containing instruction requirements.

ASTM F2061 – Standard Practice for Chemical Protective Clothing: Wearing, Care, and Maintenance Instructions describes the minimum information that needs to be provided in instructions concerning the maintenance of chemical protective clothing. It also prescribes illustrations and pictograms to be used in the instructions.

ASTM F2983 – Standard Guide for Manufacturers for Labeling and Care Instructions for Wrestling Mats requires wrestling mats to come with instructions that alert users of important issues concerning the use of the mats.

ASTM D5489 – Standard Guide for Care Symbols for Care Instructions on Textile Products contains information on symbols used in care instructions. The symbols relate to operations like washing, dying, drying, and ironing.

The above information was retrieved from the ASTM’s site.

29 CFR Part 1910: Personal Protective Equipment

29 CFR Part 1910 establishes worksite safety requirements for employers and employees to comply with, under the authority of the Occupational Safety and Health Act (OSH Act).

Some of its Parts require that employers take into account whether manufacturer’s instructions are provided with the PPE equipment.

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Subart I of 29 CFR Part 1910: Appendix B to Subpart I of Part 1910—Nonmandatory Compliance Guidelines for Hazard Assessment and Personal Protective Equipment Selection

[…]
6. Devices with adjustable features. Adjustments should be made on an individual basis for a comfortable fit that will maintain the protective device in the proper position. Particular care should be taken in fitting devices for eye protection against dust and chemical splash to ensure that the devices are sealed to the face. In addition, proper fitting of helmets is important to ensure that it will not fall off during work operations. In some cases a chin strap may be necessary to keep the helmet on an employee’s head. (Chin straps should break at a reasonably low force, however, so as to prevent a strangulation hazard). Where manufacturer’s instructions are available, they should be followed carefully.

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Additionally, some of its Parts incorporate standards (e.g ANSI standards) that may require the provision of instructions.

21 CFR Subchapter H – Medical Devices

The FDA’s Guidance on Medical Device Patient Labeling provides comprehensive guidance and explanation to importers and manufacturers of medical devices in regard to developing user instruction content. These instructions concern aspects such as:

• Setup instructions
• Operating instructions
• Storage instructions
• Safely disposal instructions
• Accessories and use instructions

The guidance document points out that importers and manufacturers should develop instructions for medical devices that explain the risks and benefits to both patients and caregivers.

The users should be able to learn the functions (e.g. treatment, diagnosis, prevention of diseases) and dangers (e.g. accidents could happen when the device is misused) of the device while reading the instructions.

Here are some examples of medical devices:

• Home pregnancy test kits
• Pacemakers
• Glucose monitors

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Guidance on Medical Device Patient Labeling; Final Guidance for Industry and FDA Reviewers, page 8: You should consider developing instructions for use when patients or lay caregivers need to:

• maintain the device;
• monitor and report on the operation or output of the device (e.g., pacemakers, glucose monitors);
• explain the operation of the device to others, such as a practitioner caring for another condition of the patient;
• explain the patient’s medical situation to others, such as when lay caregivers or others need to understand the requirements of care or the alterations of lifestyle associated with care in the use of the device;
• know how to alter their lifestyles or care regimens to properly integrate the use of the device; and/or
• know how to safely dispose of the device.

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CPSC – General Use Products

The CPSC, which regulates a large number of consumer products in the US, create regulations that require certain products to bear user instructions. The content requirement of user instruction varies from product to product.

You can refer to the CPSC’s “Manufacturer’s Guide to Developing Consumer Product Instructions” to learn how to organize the user instructions for your product in an effective way. You can download it on the CPSC’s website.

Here are some examples of products that require user instructions under CPSC rules:

• Bicycles
• Bicycle helmets
• Bunk beds
• Mowers
• Household products containing hazardous substances

For example, 16 CFR Part 1205 mentions instructions for walk-behind power lawn mowers:

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16 CFR Part 1205: Maximum operating speed means the maximum revolutions per minute (rpm) obtainable by the engine or motor under the conditions of the particular test where the term is used. For an electrically powered mower, it is the speed attained when the mower is energized from a 60 Hz alternating current source that delivers a voltage no greater than 120 V and no less than 115 V at the power input to the mower, with the mower running. For a battery-powered mower, it is the speed attained after the battery has been fully charged in accordance with the mower manufacturer’s instructions.

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User Instruction Standards

There are standards that provide requirements or guidelines for product user instructions. Below are some examples of such standards. However, note that more standards on how to structure user instructions may exist.

Standard	Description
ANSI Z535.6 – Product Safety Information in Product Manuals, Instructions and Other Collateral Materials	This standard contains requirements regarding the content and its design and placement in instructions for many different products.
IEC/IEEE 82079-1 – Preparation of information for use (instructions for use) of products Part 1: Principles and general requirements	This standard contains general principles and requirements for the design of all types of instructions for use that will be beneficial for users of products of all kinds. Here are some examples of products covered: A tin of paint Industrial machinery Turnkey-based plants or buildings
ISO/IEEE DIS 82079-2 – Preparation of information for use (instructions for use) of products Part 2: Assembly of self-assembly products	This standard contains requirements for the instructions for the use of self-assembly products.
IEC/AWI 82079-3 – Preparation of information for use (instructions for use) of products Part 3: Specific provisions for complex systems	This standard contains requirements for the instructions of use of complex systems defined as an assembly of linked parts, components, and subsystems that are linked together for a particular purpose.

User Instruction Examples

In this section, we provide some examples of different information that would be found in user instructions. The examples provided below come from US regulations or guidance documents that mention the information in the context of user information (unless stated otherwise).

Table of Contents

Although we did not find any mention of this in US regulations, most of the user manuals contain a Table of Contents. This is to show the users a summary of the manual and help them quickly navigate to the parts they are interested in reading.

Product and Company information

We could not find any regulation that set requirements for this type of information. However, it is still important to at least provide basic info about the product and company (e.g. for traceability purposes).

Intended use

Information on intended use is important because it informs the user how the product should be used. This can prevent personal injuries and damages to the product arising from the mishandling of the product.

For example, 16 CFR Part 1203.6 states that bicycle helmets must come with intended use information on the fitting and positioning of the helmet.

List of components and accessories

This type of information tells the user the number of components and accessories that come with the product. Users should be made aware of this to ensure the proper assembly and operation of the product. This can help prevent the possible breakdown of the product.

For instance, the CPSC’s guide entitled “Manufacturer’s Guide to Developing Consumer Product Instructions” mentions that when providing a product overview in the instructions, the section may include a list of product parts.

Safety warnings and compliance marks

Safety warnings and compliance marks appear on instructions to alert the user of particular hazards associated with the product. Such warnings and markings aim to prevent personal injuries from occurring to the user.

For example,16 CFR Part 1513 on bunk beds requires safety warnings to be provided in the instructions (e.g. “Do not allow children under 6 years old to use the upper bunk”).

Assembly, installation, and use instructions

This type of information is featured in instructions to inform the user how to get the product to a state in which it can function as intended. Without such information, users run the risk of damaging the product or incurring personal injuries.

For instance, 16 CFR Part 1512 requires bicycles to come with an instruction manual that must mention assembly and maintenance instructions.

Maintenance and cleaning instructions

Products may come with maintenance and cleaning instructions to inform the user how to clean and maintain their products. This ensures that the product can continue to operate as intended for a longer period and that the user does not mishandle the product.

For example, 16 CFR Part 423 requires that care labels for wearing apparel state what regular care is needed. It states that generally wearing apparel must have either washing or dry cleaning instructions.

Storage, disposal, and recycling instructions

This type of information found in instructions informs the user how to store and dispose of the product. Such instructions can prevent the breakdown of the product or unnecessary damage to the environment.

The CPSC’s guide entitled “Manufacturer’s Guide to Developing Consumer Product Instructions” suggests that information on storage and disposal should be considered.

Other Information

Other information such as important notices, warranty information, and disclaimer may also be included in the user instruction, when necessary.

Language Requirements

Generally speaking, user instructions should be written in the English language. However, in some cases, other languages may be used.

For example, the FDA labeling requirements for medical devices listed in 21 CFR 801.15 state that in the case of products that are only sold in Puerto Rico or other territories where the main language is not English, the predominant language (e.g. Spanish) can be used instead of English.