United States of America

Capitalise on the market opportunities in United States of America

USAProduct safety requirements and regulations are put in place to reduce risks, improve the quality of life and ensure fit for use. Most products entering the USA market must meet the relevant requirements of the authorities depending on the product scope. 

Where electrical products are concerned, electrical safety testing must be carried out by an approved Nationally Recognized Test Laboratory (NRTL). Medical related products have to comply with the Food and Drug Authority (FDA) requirements. Where telecoms and wireless products are concerned, Federal Communications Commission (FCC) regulations apply and for environmental products, Department of Energy (DOE) requirements apply. 

Regulations and compliance requirements can pose challenges to companies who are looking to explore new markets. You can ensure that your products successfully meet the American standards by working with a market leader, TÜV SÜD. 

TÜV SÜD fully understands the local requirements and procedures applicable in America. You can rely on our expertise and knowledge to help you access key markets efficiently while at the same time, be assured of our objectivity, integrity and professionalism.

CLICK ON THE RESPECTIVE CATEGORIES BELOW TO GET MARKET ACCESS INFORMATION TO EACH CATEGORY

  • Plug Types

    Type A

    Plug A 

    Type B

    Plug B

  • Electrical Safety

    Regulatory agency

    • Occupational Safety and Health Administration (OSHA)

    Regulations

    • Safety standards require testing and certification of products through an OSHA recognised Nationally Recognized Test Laboratory (NRTL).
    • Factory inspections are required, where applicable.
    • Compliance with CSA, UL and/or IEC standards.

    Guidelines

    • Although certification is not mandatory, it is highly recommended for marketing purposes and offers state-level authorities a sound basis for product evaluation.
    • Certified products are marked by the manufacturer with the mark of the NRTL and listed in a “Listing Book” published by the NRTL.

    Applicable product categories

    • A full list of product categories may be found here. To determine if a particular product is subject to the above regulations, please contact us.

    Our services at a glance

    • As a recognised NRTL, TÜV SÜD can provide electrical safety certification for a range of products including:
      • Electrical drives        
      • Industrial control systems       
      • IT equipment      
      • Laboratory equipment
      • Lasers
      • Power supplies, etc.
  • EMC

    Regulations

    Federal Communications Commission (FCC)

    Regulations

    • Manufacturers’ declaration is required for certain products stated in Title 47 of the CFR, Part 15 and Part 18.
    • Household appliances are exempted.

    Guidelines

    DoC PROCEDURE
    • Test the product for compliance at an accredited test laboratory.
    • Prepare a technical file.
    • Mark the product and place the required FCC notices in the user manual.
    CERTIFICATION PROCEDURE
    • Get the product tested at a Telecoms CB.
    • Submit the test report, together with other essential documents and a proposed FCC ID Number to the FCC.
    • Mark the product with the FCC ID and compliance statement, and place the required FCC notices in the user manual.

    Applicable product categories

    • Common unintentional radiators include personal computers, peripherals, receivers, radios, TV sets, and cable TV home terminals. Intentional radiators include cable-locating equipment, cordless telephones, remote control and alarm transmitters, field-disturbance sensors for opening doors, and spread-spectrum systems for wideband data transmission.
    • To determine if a particular product is subject to the above regulations, please contact us.

    Our services at a glance

    As a Telecoms CB, TÜV SÜD is authorised by the FCC to issue grants for a wide range of equipment within the following categories:

    • Licensed Radio Service Equipment
    • Radio Equipment (intentional and unintentional radiators)
    • Unlicensed Radio Equipment
    • Wireline Terminal Equipment
  • Environmental

    Regulatory agency

    Department of Energy (DOE)

    Regulations

    ENERGY EFFICIENY

    • Minimum Energy Performance Standards (MEPS) are required for many products.Household appliances are exempted.
    • Mandatory Energy Guide labelling is required for certain products.
    RoHS
    • Californian RoHS under the Electronic Waste Recycling Act 2003 applies.

    Guidelines 

    • Manufacturers must submit energy use data to the DOE and FTC stating that it complies with the regulations. They must also report to DOE and FTC when a new model is introduced or an existing one is discontinued.
    • Information on EnergyGuide labels must be based on Department of Energy (DOE) test procedures.

    Applicable product categories

    Product categories that require mandatory labelling include:

    • Ballasts
    • Freezers      
    • Water heaters
    • Heaters
    • Fluorescent lamps
    • Room air conditioners
    • Clothes washers
    • Refrigerators     
    • Central air conditioners   
    • Heat pumps
    • Boilers
    • Furnaces
    • Dishwashers

    A full list of product categories may be found here. To determine if a particular product is subject to the above regulations, please contact us.

  • Medical Devices

    Regulatory agency

    • Food and Drug Administration (FDA)

    Regulations

    • Medical devices distributed in the United Sates are subject to general controls, pre-marketing and post- marketing regulatory controls.
    • Most Class I devices are exempt from 510(k) premarket notification. The manufacturer is required to register their establishment and list their device on the database.
    • Most Class II, but also some Class I and Class III medical devices requiring clearance for US market entry can only attain acceptance via a premarket notification procedure 510(k).A DoC with the MERCOSUR legislation is required for Class I devices.
    • Most Class III devices typically require Pre-Market Approval (PMA).
    • Manufacturers must comply with the Quality System Regulation 21 CFR Part 820.
    • After product approval (PMA) or 510(k) clearance, the FDA can carry out a production site inspection at any time in order to verify that the manufacturer is in compliance with the Quality System Regulation. As a rule, this encompasses management, development, corrective and preventive action, as well as production and process control.

    Guidelines

    • Manufacturers must register their establishments and list their devices with the FDA.
    • 510(k): A 510(k) submission is based on the comparison of the new device with devices already marketed in the US, which allows the FDA to determine whether a device is safe and effective.
    • PMA: Significant scientific review of the safety and effectiveness of the device.

    Applicable product categories

    • To determine if a particular product is subject to the above regulations, please contact us.

    Our services at a glance

    • TÜV SÜD is authorised by the FDA under the Accredited Persons program to review 510(k) applications on behalf of medical device manufacturers for all Third Party eligible Class I and Class II devices as well as to provide Third-Party FDA Inspections or mock inspections based on the FDA regulations.
    • TÜV SÜD is also a Nationally Recognised Testing Laboratory (NRTL) for the US market and is able to test your device according to test standards such as UL 60601-1. The electrical and mechanical safety testing are conducted in accordance to IEC 60601-1 which forms the basis for NRTL medical device certification. This registration is required for wound care materials, surgical devices or material, hygienic products, dentistry products, family planning products, implantable prosthesis, diagnostic agents, reagents, medical equipment and instruments, external prosthesis, orthosis and functional aids.
    • Telecom

      Regulatory agency

      • Administrative Council for Terminal Attachments (ACTA)

      Regulations

      • Declaration of Compliance (DoC) and compliance to CFR Part 68 are required.  

      Guidelines

      DoC PROCEDURE

      • Test the product for compliance at an accredited test laboratory.
      • Prepare a technical file.
      • Mark the product and place the requirement FCC notices in the user manual.
      • Prepare and sign a DoC.

      CERTIFICATION PROCEDURE

      • Get the product tested at a telecom CB.
      • Submit the test report, together with other essential documents and a proposed FCC ID Number to the FCC.
      • Mark the product with the FCC ID and compliance statement, and place the required FCC notices in the user manual.
    • Wireless

      Regulatory agency

      • Federal Communications Commission (FCC)

      Regulations

      • Compliance to CFR Part 15 is required including testing conducted by an accredited test laboratory.  
      • DoC or Certification from a telecoms CB is required.
      • As a general guide:
      • DoC or Certification is required for unintentional radiators.
      • Certification is required for intentional radiators.

      Guidelines

      DoC PROCEDURE

      • Test the product for compliance at an accredited test laboratory.
      • Prepare a technical file.
      • Mark the product and place the requirement FCC notices in the user manual.
      • Prepare and sign a DoC.

      CERTIFICATION PROCEDURE 

      • Get the product tested at a telecom CB.
      • Submit the test report, together with other essential documents and a proposed FCC ID Number to the FCC.
      • Mark the product with the FCC ID and compliance statement, and place the required FCC notices in the user manual.

    EXPLORE

    E-book

    Market access for electrical goods

    Overview of compliance requirements worldwide for electrical and electronic goods.

    Learn more

    VIEW ALL RESOURCES

    Next Steps