General Requirements. If a children's product undergoes a material change in product design or manufacturing process, including the sourcing of component parts, which a manufacturer exercising due care knows, or should know, could affect the product's ability to comply with the applicable children's product safety rules, the manufacturer must submit a sufficient number of samples of the materially changed children's product for testing by a third party conformity assessment body and issue a new Children's Product Certificate. The number of samples submitted must be sufficient to provide a high degree of assurance that the materially changed component part or finished product complies with the applicable children's product safety rules. A manufacturer of a children's product that undergoes a material change cannot issue a new Children's Product Certificate for the product until the product meets the requirements of the applicable children's product safety rules. The extent of such testing may depend on the nature of the material change. When a material change is limited to a component part of the finished children's product and does not affect the ability of other component parts of the children's product or the finished children's product to comply with other applicable children's product safety rules, a manufacturer may issue a new Children's Product Certificate based on the earlier third party certification tests and on test results of the changed component part conducted by a third party conformity assessment body. A manufacturer must exercise due care to ensure that any component part undergoing component part-level testing is identical in all material respects to the component part on the finished children's product. Changes that cause a children's product safety rule to no longer apply to a children's product are not considered to be material changes.

Product Design. For purposes of this subpart, the term “product design” includes all component parts, their composition, and their interaction and functionality when assembled. To determine which children's product safety rules apply to a children's product, a manufacturer should examine the product design for the children's product as received or assembled by the consumer.

Manufacturing Process. A material change in the manufacturing process is a change in how the children's product is made that could affect the finished children's product's ability to comply with the applicable children's product safety rules. For each change in the manufacturing process, a manufacturer should exercise due care to determine if compliance to an existing applicable children's product safety rule could be affected, or if the change results in a newly applicable children's product safety rule.

Sourcing of Component Parts. A material change in the sourcing of component parts results when the replacement of one component part of a children's product with another component part could affect compliance with the applicable children's product safety rule. This includes, but is not limited to, changes in component part composition, component part supplier, or the use of a different component part from the same supplier who provided the initial component part.