FDA Crash Cart Regulations

The Food and Drug Administration, FDA, is an agency responsible for protecting the public's health and safety by setting standards and regulations for medications, vaccines, medical devices as well as food, cosmetics, tobacco and dietary supplements. Crash carts fall into the realm of FDA regulation.

Identification

• The FDA identifies a crash cart, or cardiopulmonary emergency cart, as a device intended to store supplies required for emergency treatment.

Classification

• The FDA markets this device as a Class I, meaning it is exempt from premarket notification procedures and the good manufacturing practice requirements. The details of this can be found in the Code of Federal Regulations Title 21.

Content

• The FDA considers the crash cart only in this regulation, not the equipment stored on it. The regulations for the content of the device, such as equipment used for cardiopulmonary resuscitation is separate from that of the transportation device itself .