Product User Instructions Requirements in the United States: An Overview

User instructions and manuals are something we often take for granted without giving second thoughts. What many importers and manufacturers may not be aware of is that providing user instructions is often mandatory. In this guide, provide some examples concerning product regulations and standards that cover user instructions requirements in the United States.

Further, we also list companies offering user instruction writing services for the US market.

Which products require user instructions in the United States?

Many consumer products that are sold in the United States are required to include user instructions. The instructions are intended to provide comprehensive information to the users for their better understanding of the installation, operation, and maintenance of the products.

In this section, we focus on categories of products for which there exist specific acts and standards that require user instructions.

CPSIA: Children’s Products

Children’s products, including toys and child care products that are marketed in the United States, must conform to the applicable safety standards dictated by the CPSIA, which often include guidelines on user instructions.

For example, ASTM F963 Toy Safety Standard requires several categories of products to bear user instructions:

• Crib and playpen toys
• Battery-operated toys
• Toys in contact with food
• Toy chests

The instructions for each product should help the user to assemble, install and maintain the product. They should also indicate potential hazards via specific warning statements, and other information that might help consumers using the product safely.

Besides toys, CPSIA also requires other categories of children products to comply with the corresponding ASTM standards instructions guidelines:

• Soft infant and toddler carriers
• Frame child carriers
• Sling carriers
• Cribs
• High chairs
• Toddler beds

Importers and manufacturers should provide instructive information to the consumers on assembly, recommended use position, and other relevant information regarding the usage or precautions for these products. You can also consult the CPSC small business ombudsman for further guidance.

FCC Part 15: Electronics

The Federal Communications Commission (FCC) establishes the technical requirements regarding the safety and marketing of intentional, unintentional, and incidental radiators in the United States. These requirements are codified in Title 47 CFR Part 15.

The scope of the regulation is broad, including household appliances, mobile devices, and electronic accessories. Here some examples of regulated products:

• Bluetooth speakers
• Active RFID tags
• Wireless chargers
• USB sticks
• Wired mouses

The FCC 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
• Operational frequencies
• Components installation and use

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

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Quote from Section 15.21 Information to User, Title 47 CFR Part 15:

“The user’s 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.”

Source: Link

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

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Quote from Section 15.27 Special Accessories, Title 47 CFR Part 15:

“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.”

Source: Link

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UL Standards: Electronics

Many UL standards for electronic products specify requirements for the assembly, installation, and use instructions. They might also specify warning statements.

For example, the instructions of UL 153 – Portable Electric Luminaires for portable cabinet lights aim at reducing the risk of fire, electric shock, or injury to the users.

Here are some examples of other UL safety standards that require user instructions:

• UL 1598 – Luminaires
• UL 1642 – Lithium Batteries
• UL 6500 – Audio/Video and Musical Instrument Apparatuses for Household, Commercial and Similar General Uses
• UL 60950 – Information Technology Equipment

Below, we quote the “Style Manual for UL Standards for Safety”. The manual explains that a standard written for a product that requires specific procedures should include instructions.

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Quote from Part III – Content of Traditional Elements – Instructions, Style Manual for UL Standards for Safety:

“3.1 A standard that covers a product required to be installed in accordance with recognized installation standards or operating procedures shall include installation instructions. Installation instructions that are combined with instructions for use, maintenance, operation, or any combination of these factors, meet the intent of this requirement.”

Source: Link

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OSH Act: Personal Protective Equipment

The Occupational Safety and Health Act (OSH Act) establishes worksite safety requirements for employers and employees to comply with.

One of the requirements is that employers must provide compliant personal protective equipment for employees in worksites in order to avoid harms and casualties caused by work. In order to be compliant, these products not only have to pass specific test methods, but they also have to include the necessary instructions to permit the workers to wear them safely.

The OSH Act incorporates a list of ANSI and ASTM standards for personal protective equipment in CFR Title 29, Part 1910. These standards cover protective wear for feet, hands, head, eyes, and other parts of the body. Here some examples of standards that include product instructions requirements:

a. ASTM F2412 – Standard Test Methods for Foot Protection

b. ASTM F2413 – Standard Specification for Performance Requirements for Protective Footwear

c. ANSI/ISEA Z89.1 – Industrial Head Protection

d. ANSI Z89.2 – Safety Requirements for Industrial Protective Helmets for Electrical Workers

FDA: 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 the user instruction content. These instructions concern aspects such as:

• Setup instructions
• Operating instructions
• Storage instructions
• Safely disposal instructions
• Accessories set up 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 misuses, precautions, contradictions) of the device while reading the instructions.

Here some examples of medical devices that require instructions:

• Home pregnancy test kits
• COVID-test kits
• Pacemakers
• Glucose monitors
• Blood pressure gauge

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Quote from Section “When should you use medical device patient labeling?”, Guidance on Medical Device Patient Labeling:

“You should consider developing instructions for use when patients or lay caregivers need to:

a. maintain the device;

b. monitor and report on the operation or output of the device (e.g., pacemakers, glucose monitors);

c. explain the operation of the device to others, such as a practitioner caring for another condition of the patient;

d. 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;

e. know how to alter their lifestyles or care regimens to properly integrate the use of the device; and/or

f. know how to safely dispose of the device.”

Source: Link

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CPSC: General Consumer Products

The CPSC, which regulates a large number of consumer products in the US, requires 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 other products that require user instructions under CPSC rules:

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

For example, Title 16 Part 1513 requires that instructions should accompany bunk beds, and include the following safety warnings:

a. Children under 6 years old should not use the upper bunk

b. Use guardrails on both sides of the upper bunk

c. No horseplaying on the under beds

d. More than one person from the upper bunk is not allowed

e. Use a ladder for entering or leaving the upper bunk.

f. If the bunk bed is placed next to a wall, the guardrail should be placed against the wall to prevent entrapment hazards.

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Quote from Title 16 Part 1512.19 – Requirements for Bicycles:

“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 the 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.”

Source: Link

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User Instruction Examples

As we saw in the first part of this guide, each regulation might have its own requirements when compiling user instructions. This means that different types of instructions might be required for different products, which are covered by different regulations and standards.

In general, user instruction should provide clear guidance for users on how to safely install, operate, maintain, store or dispose of the product. Below we provide a short description of some of the main elements that are usually included in the user instructions.

Table of Content

Most of the user manuals contain a page(s) of Table of Content. This is to show the users a brief summary of the manual and help them quickly navigate to the parts they are interested to read.

Product and Company information

Product and company information is often provided on the first pages of the user instructions. This might include the following product information:

• Product name
• Model number, batch ID, and/or lot number
• Date of manufacturer
• Product characteristics (e.g. size, color, dimension, voltage)

The following company information is also important:

• Company name
• Postal address
• Contact information

Intended use

The user instructions should explain the intended purposes of the product. Let’s take a computer stand as an example. The description of the intended use could specify these elements:

a. Explanation of the intended purpose (e.g. a placement platform for laptop or electronic pad, not for a desktop computer or other objects)

b. Explanation of the maximum load or dimension of the laptop (e.g. not supposed to hold laptop exceeding 4kgs, and 30 cm x 20 cm)

c. Intended use environment (e.g. use on a flat table or desk)

d. Different methods of using the product (e.g. the height could be adjusted between 0-10 cm)

List of components and accessories

Before explaining the methods for installation, operation, and maintenance of a product, the user manual might devote a section to introduce components, spare parts, or other accessories. For example, the material list for a baby crib could reveal the following information:

• Head board (1 pc)
• Foot board (1 pc)
• Side board (2 pcs)
• Stabilizer bar (1 pc)
• Mattress spring (1 pc)
• Bolts (4 pcs)

Sometimes, the importer or manufacturer also provides the dimension (i.e. length, width, etc), color, illustration, image, or other information of the component to help users quickly recognize and understand the parts and their functions.

Safety warnings and compliance marks

For products that entail risks or dangers, the user instructions should indicate them by providing safety warning signs or warning statements.

Take again a baby’s crib as an example. The safety warning could cover these aspects:

• Entrapment hazards
• Suffocation hazards
• Strangulation hazards
• Flammability hazards
• Fall hazards
• Sharp hazard
• Age limit

If the baby’s crib complies with certain standards (e.g. ASTM F1169), this information should also be specified.

You can consult the specific standard developed by ANSI, ANSI Z535.6 – Product Safety Information in Product Manuals, Instructions, and Other Collateral Materials, in order to learn how to information such as the following:

• Signal words
• Safety messages
• Safety symbols

Assembly, installation, and use instructions

For products that are not fully assembled, the instruction manual should explain to the users the proper way to assemble and install the product.

Let’s stick to the example of a baby crib. The importer or manufacturer should use clear language and, if necessary, illustrative figures, or enlarged drawings to break down each assembling procedure.

For instance, the steps to assemble a baby crib could look as follows:

1.1 Insert nut 1 (20mm) through the holes in the headboard from the backside

1.2 Insert bolt 2 (65mm) through the top and bottom holes in the sideboard and connect to the headboard

1.3 Repeat STEP 1.1 for other sideboards

Use instructions should be provided after explaining the assembly and installation procedures to educate users on the proper methods of using the product.

Maintenance and cleaning instructions

This section aims to introduce maintenance and cleaning methods for the product in order to maintain its normal functioning or increase the shelf life.

For example, the maintenance instructions of a baby crib might suggest the users check the fastening situation of the sideboards, batten, or bolts in order to maintain the stability of the crib to prevent falling or entrapment hazards.

Storage, disposal, and recycling instructions

Storage instructions might be highly relevant for some classes of medical devices, household products, food, and more.

Disposal instructions might concern batteries, medical devices, recyclable products, and others.

In particular, the US Environmental Protection Agency (EPA) suggests the disposal and recycling methods for several types of products and materials, including:

• Batteries
• Plastics
• Glass

Therefore, when applicable, manufacturers can refer to the EPA, other federal or state institutes’ instructions when providing disposal and recycling instruction to users.

Other Information

Other information such as important notices, warranty information, and disclaimer might 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, the Spanish language might also be required.

For example, FDA’s requirements for medical device labeling explained in 21 CFR 801.15 state that, all words, statements, and other information that are required to be disclosed should be written in English. If a medical device is distributed in US territories whose predominant language is not English (e.g. Puerto Rico), then the predominant language shall also be used in the labeling and instructions (e.g. Spanish).

This is also mentioned on the FDA website.

User Instructions Service Providers

In this section, we introduce several companies that provide user instructions content writing, development, and modification services for importers and manufacturers.

Impala Services

Founded in 2005, Impala Services provides user manual creation, polishing, and modification services for manufacturers, private labelers, and distributors in the industry of household products, power tools, and audio & video.

According to the information on Impala’s official website, over 75% of their writers are qualified with a Master’s Degree in Technical Communication and they are able to create tailored-made user manual content compliant with the national standards of the United States, Germany, Japan, and other European and Asian countries.

Service Categories

• User manuals
• Assembly instructions
• Quick start guides
• 3D solutions
• Packaging information

Company Information

• Year of Registration: 2005
• Locations: Hong Kong, Beijing, Shenzhen

HQ Address: Unit E & F, 7/F, Selwyn Factory Building, 404 Kwun Tong Road, Kwun Tong, Hong Kong

F2 Labs

F2 Labs is a company with more than two decades of experience in performing safety evaluations and lab testing services in the EMC industry.

F2 Labs assists clients in creating user instruction manuals, product labels, compliance statements, and other documents. Their services cover products such as the following:

• Battery chargers
• Lighting products
• Medical electrical equipment
• Wireless devices

Also, they can help clients in the following markets:

• European Union
• United States
• Canada
• Australia
• New Zealand
• Brazil
• Several Asian countries

According to their official website, the facilities of F2 Labs are accredited by the American Association of Laboratory Accreditation (A2LA) and the test reports issued by F2 Labs are accepted worldwide by certification organizations such as various Notified Bodies and OSHA accredited NRTLs.

Service Categories

• User instruction manuals
• Product labeling
• Compliance statements
• Preliminary design reviews

Company Information

• Year of Registration: 1991
• Locations: Maryland, Indiana, Ohio

HQ Address: 26501 Ridge Road., Damascus, Maryland, the United States

Info Pros

Info Pros was founded in Colorado who has been committed to providing technical documentation drafting and courseware development services since 1994.

The core team members of Info Pros are composed of technical writers, desktop publishers, and illustrators, in addition, the team members can visit the clients or worksites in person if needed to gather information to ensure the appropriate knowledge, tone, reading level, and layout customized to communicate directly to the target audience.

Info Pros has served clients like American Express, The Home Depot, Cisco Systems, and Eaton.

Service Categories

• Installation manuals
• Operation manuals
• Maintenance manuals

Company Information

• Year of Registration: 1994
• Locations: Colorado, New York, North Carolina, and Wisconsin

HQ Address: Colorado Springs, Colorado, United States

INSTRKTIV

INSTRKTIV is a German company that offers legal advice and writing services on user manuals for products manufactured in and imported to the US.

INSTRKTIV’s team is made up of talents from the industry of electronic engineering, industrial design, and legal profession who are capable of providing the users comprehensive knowledge and assistance against a large array of product categories.

Service Categories

• Installation manuals
• User guides
• Maintenance manuals
• Work instructions
• Packing instructions
• Training manuals

Company Information

• Year of Registration: 2006
• Locations: Germany, The Netherlands, United States

HQ Address: Lohmühlenstraße 65, 12435 Berlin, Germany

PaxMed International

Established in 1990, PaxMed International was founded to assist medical device companies to develop and customize biomaterials used in implantable devices as well as helping these companies to launch in the US and international markets.

PaxMed has successfully helped clients from medical device industries in the design, manufacture, packaging, labeling, and storage, and other pre-market procedures. PaxMed is able to create user manuals and instruction guides for different classes of medical devices in accordance with the following standards and regulations:

• FDA Quality System Requirements (21 CFR 820)
• Canada Medical Device Licence (CMDCAS)
• The international standard for quality management systems (ISO 13485)
• EU Medical Devices Regulation

Service Categories

• Pre-market consultation
• User manuals
• Product packaging and labeling

Company Information

• Year of Registration: 1990
• Locations: the United States

HQ Address: El Camino Real, Suite 400, San Diego, California, the United States