How to make a toy prototype and take it to a tested first run

The steps

1. Decide the age grade before you sketch. The US toy standard covers playthings for children under 14 years of age^[1], and third party testing and certification apply to products meant mainly for children 12 years of age or younger^[1]. Within that range the age grade drives the design, so pick it first. It is not only what the box says: when the CPSC decides whether a toy is meant for babies and toddlers, it weighs the stated age if it is reasonable, the advertising, promotion, and marketing of the article^[2], and whether the toy is commonly recognized as a baby toy. A soft toy photographed in a crib is likely to be treated as a baby toy, whatever the label says.
2. Build a rough play model and watch children use it. Foam, card, 3D printed parts, a hand-sewn mock-up or an existing toy cut apart will do. With parents present, watch children in the target age play with it and note what they pull, twist, bite and throw. The lab's use-and-abuse tests later simulate that kind of handling, and a toy that comes apart in a child's hands will come apart there too.
3. Design out the hazards your age grade triggers. For a toy meant for children under 3 years (36 months) of age^[2], no part may fit the small parts test cylinder, which approximates the size of the fully expanded throat of a child under three years old^[3]. That includes pieces that break off in use-and-abuse testing. Plush is named in the rule (stuffed, plush, and flocked animals and other figures^[2]), so hard eyes, noses and buttons are the parts to design around, while loose bits of paper, fabric, yarn, fuzz, elastic, string^[3] are not counted as small parts. Magnets that are or can become small parts need a flux index less than 50^[1].
4. Plan the warning label if the toy is for older children. A toy or game for children at least three years old but less than six years of age^[4] that includes a small part must carry the choking hazard warning, and so must its advertising, which must use the same warning label^[3]. In a board game, dice and tokens are usually small parts. Balls get their own warning: a small ball is one that passes through a hole 1.75 inches (44.4 mm)^[4] across.
5. Choose materials that pass the chemistry tests. Accessible parts of a children's product may not contain more than 100 ppm^[5] lead, and paint and similar surface coatings may not exceed 0.009 percent^[6] lead by weight of their nonvolatile content. Toys may not contain more than 0.1 percent^[7] of the listed phthalates, and that limit applies to any plasticized component part^[7], so soft vinyl heads, squeeze parts and coated fabrics all count. Name the resin, paint and fabric for each component in your spec, and ask for the material suppliers' own test reports before a sample is made.
6. Turn the prototype into a production spec. List each component with its material, colour reference and finish; the stitching and seam allowance for plush, whose seams must not rip during testing^[1]; the age grade, warning text and tracking label text; and the packaging. Add CAD files and drawings for moulded parts, and ask for the mould cost and the unit price as separate figures.
7. Approve a production sample, then test that sample, not the prototype. Certification testing is done on the product itself or on samples identical in all material respects to the children's product^[8]. A 3D printed or hand-sewn prototype is neither. Sign off a pre-production sample built from the production materials on the production tooling, then have units made that way tested at a CPSC-accepted laboratory.
8. Issue the Children's Product Certificate. The rules require domestic manufacturers and importers^[9] of children's products to certify compliance in writing, based on the lab's results. When the goods are made overseas and you import them, the importer is you. The certificate states the city (or administrative region), state (if applicable), and country where the product was manufactured^[9], and since July 8, 2026^[9] importers of most regulated consumer products must file their certificates electronically with US Customs and Border Protection.
9. Put tracking labels on the toy and the box. Permanent tracking marks go on the product and its packaging, to the extent practicable^[10], and they must show the name of the manufacturer, importer or private labeler, the location and date of production^[10], and the batch or run number. Write the exact text and where it sits into the spec rather than leaving it to the factory.
10. Keep the test current after launch. Children's products need periodic third party testing, by default at least once a year^[8], and a material change in design or manufacturing process, including the sourcing of component parts^[8], that could affect compliance means new testing and a new certificate. A factory that quietly switches paint or resin suppliers has changed your product, so require notice of any change in your purchase terms and book a quality inspection on each run.

Which edition of the toy standard applies

The standard in force is ASTM F963-23^[11]. The effective date of each new edition is tied to the date of manufacture (regardless of whether the product was manufactured outside of the US)^[1], and toys manufactured after April 20, 2024^[1] must meet this one. For a toy made overseas, the factory's production date is what counts, so a reorder of an older design must meet the current edition even if the first run met an earlier one. Make sure the lab has the production date with the samples.

Duty and the age grade at the border

Toys, dolls and puzzles share one heading in the US tariff schedule, and its general duty rate is Free^[12]. Additional duties that depend on the country of origin can apply on top of the general rate, so price each country on landed cost, as the import duty guide shows. The heading's statistical lines split toys by age (under 3 years of age, and 3 to 12 years of age^[12]), so the age grade you choose in the first step also goes on the customs entry. Keep it the same on the entry, the certificate, the box and the listing.

What a toy's first run costs, testing included

Lab testing is charged per style, so the number of styles changes the cost per unit, not only the factory price. The example below is a plush toy for babies and toddlers, made overseas.

Two plush styles, 1,500 units each

Line	Cost
Prototype, two factory sample rounds and the pre-production sample	$600
Third party lab testing, two styles at $450 each	$900
Production, 3,000 units at $3.20	$9,600
Sea freight, cargo insurance, customs broker and port charges	$1,450
Additional duties for the country of origin, at 10% (assumed) of the goods price	$960
Pre-shipment inspection	$330
Landed cost of the run, before samples and testing	$12,340
Landed cost per unit, before samples and testing	$4.11
Landed cost per unit, with samples and testing	$4.61

The same 3,000 units split across six styles of 500 each would need six tests costing $2,700, which lifts the landed cost per unit to about $5.21 before any extra sample rounds.

Illustrative figures, not a quote. Real prices depend on the spec, quantity and factory.

In this example, samples and testing add more per unit than the whole freight line does. Launch with fewer styles and more units of each. Before adding a colourway, ask the lab whether it needs its own test, since a new paint, dye or fabric can be a material change.

Getting toy quotes

Send us the production spec with the age grade, the material of every component, the warning and tracking label text and the quantity per style, and budget the lab testing per style from the start. We introduce you to toy factories that fit, overseas first, each one named, or tell you if none does. It is free for brands. The factories quote you directly, so set each per unit price against your retail price with the testing and duty added. If you import the toys, you are the importer who issues the certificate, whoever made them.