Regulatory Approvals

Personal breathalyzers are cleared by the Federal Food and Drug Administration (FDA)

All breath alcohol testers that are allowed to be distributed and sold in the United States for personal use must have FDA clearance. Many do not. Always enquire as to the FDA status of the breathalyzer you wish to purchase.

The FDA is responsible for protecting the public health by assuring the safety and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and other products. Personal breathalyzers fall under the "medical device" category and are required by US law to be FDA cleared for consumer sale and use. An important component of the FDA in protecting public safety is to oversee the manufacturing, performance, and safety of these devices.

The FDA has issued recalls for breathalyzers that have not met FDA standards. This is a serious offense. U.S. Consumers should insist that a breathalyzer they purchase has been FDA cleared.

CE Approval

The CE marking (also known as the CE mark) is mandatory on many products placed for sales on the market in Europe. The CE marking certifies that a product has met European Union (EU) consumer safety, health or environmental requirements. There are numerous "Agreements on Mutual Recognition of Conformity Assessment" between the European Union and other countries such as the USA, Canada, Japan, Australia, New Zealand and Israel. Consequently the CE mark is now found on many products from these countries.

FCC Classification

The Federal Communications Commission (FCC) is an independent United States government agency charged with regulating interstate and international communications by radio, television, wire, satellite and cable. LifeGuard was tested and approved not to generate interference in other nearby devices and to resist malfunctioning if operated in an area with interference.

Personal vs. Professional Use Alcohol Testing

LifeGuard is classified and regulated as a "Consumer" product as opposed to a "Professional" use alcohol breath testing device. As a Consumer product, LifeGuard is subject to FDA regulatory oversight. Professional use breath alcohol testers are generally regulated and approved by the National Highway Traffic Safety Administration (NHTSA), a part of the U.S. Department of Transportation.

Lifeloc also designs and manufactures a wide range of these professional use alcohol breath testing instruments for Law Enforcement, Education, Corrections and the Workplace. These products may be seen at www.lifeloc.com