- Site
- North America
- Mark / regulation
- 6
- Market
- United States
01Entering This Market
The US has no single umbrella mark like CE; authority is distributed among different federal agencies, each operating its own regime. Entering the US market therefore means separately meeting the requirements of each agency applicable to the product, not obtaining a single certificate. Additional state-level requirements may also apply.
02Background to the Regime
The United States conformity system does not sit under a single roof, and this is the first step in understanding the regime. Where a single mark in the EU represents many regulations, here each product group meets its own federal agency, its own legislation and its own form of evidence: the communications authority for radio products, the health authority for medical devices and food, the product safety commission for consumer products, the transport authority for vehicles and the environmental authority for emissions and chemicals.
The second structural distinction is that electrical product safety does not require a federal mark. Here the compelling force is not legislation but WORKPLACE SAFETY LEGISLATION, insurance companies, local electrical codes and the specifications of retail chains. These forces make it effectively mandatory for a product to be listed by a recognised testing laboratory; that is, a mark that is legally voluntary becomes commercially compulsory.
The recognised testing laboratory arrangement is the institutional expression of this: the workplace safety authority recognises particular laboratories for particular standards and that laboratory's mark is accepted in the field. No single laboratory holds a monopoly; several recognised laboratories can list against the same standard.
The third defining feature is the enforcement culture. Control usually begins not before placing on the market but with a complaint, an accident or a customs intervention; its outcome is recall, a sales stop and financial penalties. In consumer products, recall decisions are published openly and leave a lasting effect on the brand.
State-level regulations sit on top of the federal layer and cannot be treated as out of scope: chemical warning obligations, energy efficiency registrations and bans on certain substances arise from state legislation. A product may be federally compliant and still not be fit for sale in certain states.
03Acceptance of Foreign Test Reports and Documents
- For radio products, testing must be carried out in a laboratory recognised by the authority; the laboratory may be outside the country but must appear on the recognised list.
- The accepted evidence in electrical safety is LISTING by a recognised testing laboratory; a safety certificate obtained in another country does not take the place of that listing.
- A CB Scheme report can be used as input and reduces the testing burden; but national differences and the laboratory's own factory inspection process run separately.
- For children's products, the use of a third-party laboratory is mandatory and the laboratory must be accepted by the commission; a manufacturer cannot submit its own testing as evidence.
- For medical devices and food contact products, foreign certificates are not accepted; the notification or approval route of the relevant authority is followed and a representative established in the country is appointed.
04Defining Features of the Regime
- There is no single umbrella mark; FCC, FDA, CPSC and EPA operate separate regimes
- There is no federal certification requirement for electrical products; the obligation arises through OSHA, the national electrical code, and insurance conditions
- NRTL listing (UL, ETL, CSA, etc.) is in practice a market-entry condition
- FCC certification and an FCC ID are mandatory for devices that intentionally radiate radio signals
- Manufacturers outside the US must appoint a US-based responsible party with the FCC
- State-level notification obligations such as California's Proposition 65 may also apply
05Local Representative and Responsible Party
The FCC requires manufacturers outside the US to appoint and register a US-based responsible party (US Agent for Service of Process). For products under FDA jurisdiction, a US-based agent (US Agent) is mandatory and part of facility registration. For other products, although there is no legal representative requirement, having a US-based importer is practically necessary in terms of the chain of responsibility.
07Entry Process
- 01Scope DeterminationIt is determined which legislation and marking scope the product falls under in the target market. This step defines the entire process; getting it wrong wastes all subsequent work.
- 02Determining Applicable StandardsThe standards accepted by the market and any national deviations are identified. The same IEC standard may apply with different deviations in different markets.
- 03Establishing the Test PlanIt is assessed which part of existing test reports will be accepted; missing tests are planned. A CB Scheme report, if available, reduces retesting.
- 04Local Party and RegistrationIf the market requires an established representative, importer or applicant, this party is designated and the necessary registrations are made.
- 05Tests and Technical FileTests are conducted and the technical file is prepared. Some markets require testing to be performed within their own country.
- 06Certification or DeclarationDepending on the market's regime, a manufacturer's declaration is drawn up or a certificate is obtained from the authorised body; a factory audit is carried out if required.
- 07Marking and LabellingThe mark and label are applied according to the market's format and language rules. The language requirement is checked at customs in most markets.
- 08Shipment and CustomsIf a pre-shipment document is required, it is obtained; the document set to be presented at customs is completed.
08Customs and Labelling
- Country of origin marking is a customs requirement
- For products under FCC jurisdiction, the FCC ID and user information text are marked on the product
- The NRTL listing mark is the primary evidence sought during field inspection
- For children's products, a traceability label and third-party test certificate are required under CPSIA
- For energy-consuming products, DOE efficiency requirements and, where required, an energy label apply
09Common Mistakes
- Assuming CE marking is valid in the US — standards and grid conditions differ
- Assuming an approved radio module's FCC ID can be used unconditionally in the final product
- Selling to consumers a product tested to Class A (industrial) limits; consumer products must meet Class B
- Not appointing a US-based responsible party
- Overlooking state-level requirements (Proposition 65, state energy rules)
10Calendar
The certification timeline varies with the product, the required test workload, sample shipping time and the authority's workload; for this reason, no duration in days or weeks is given on these pages. The main factors determining the timeline are: whether testing must be performed in the target country, whether a factory audit is required, the time to appoint a local representative, and the current maturity of the technical file. A realistic timeline for your product is provided in writing at the quote stage.
Market access regimes change frequently: scope lists are updated, transition periods are extended, new requirements are added. These pages describe the structure of the regime and who bears the obligation; the applicable scope and dates for your product are confirmed from the current legislative text at the quote stage.
11Frequently Asked Questions
Is UL mandatory?
There is no federal requirement specifically for UL; what is required is that electrical equipment used at a workplace be approved by an NRTL. UL is one of these NRTLs; others such as ETL and CSA are accepted as equivalent.
What is the difference between Class A and Class B?
Class A is for commercial and industrial environments, while Class B is for general use including residential settings and has stricter limits. A product to be sold to consumers must meet Class B.
United States roadmap for
Tell us about your product; we'll share the required steps, documents and timeline in writing.