Interpretation ID: aiam5111

Mr. Eugene Berk Food and Drug Administration Center for Devices and Radiological Health Office of Compliance and Surveillance 1390 Piccard Dr. Rockville, MD 20850; Mr. Eugene Berk Food and Drug Administration Center for Devices and Radiological Health Office of Compliance and Surveillance 1390 Piccard Dr. Rockville
MD 20850;

"Dear Mr. Berk: This follows up on telephone conversations between yo and Deirdre Fujita of my staff about a letter you received from the Medical Device Inspection Company (MDI) concerning the 'Tumble Forms LifeSeat.' While much of the information in the letter is subject to a claim of confidentiality, Ms. Carolann Kotula-Cook of MDI told us that we can provide, for purposes of a letter that will be placed in the public docket, the following description of the LifeSeat. The LifeSeat is described by MDI as 'a safety seat designed to protect children who are riding in emergency medical vehicles. The seat is designed to be secured to the ambulance stretcher or cot... and may also be secured to the vehicle's captain's chair.' You ask whether the LifeSeat is a 'child restraint system' regulated by Federal Motor Vehicle Safety Standard No. 213, 'Child Restraint Systems.' As discussed below, the answer is yes. Standard No. 213 specifies requirements for child restraint systems used in motor vehicles and aircraft, to reduce the number of children killed or injured in motor vehicle crashes and in aircraft. The term 'child restraint system' is defined in S4 of the standard as 'any device except Type I or Type II seat belts, designed for use in a motor vehicle or aircraft to restrain, seat, or position children who weigh 50 pounds or less.' As described in MDI's letter, the LifeSeat meets the child restraint system definition, since it is designed to restrain or seat a child in a motor vehicle. Under the National Traffic and Motor Vehicle Safety Act, each child restraint system that is sold in or imported into the United States must be certified as complying with Standard No. 213. Since the LifeSeat is a child restraint system, it must be certified as complying with Standard No. 213. We informed Ms. Kotula-Cook that it appears the LifeSeat would not comply with some of Standard No. 213's requirements. We have sent her a copy of the standard, and an information sheet for manufacturers of motor vehicles and motor vehicle equipment. The information sheet describes manufacturers' responsibilities under Federal law for manufacturing vehicles and items of equipment, such as the responsibility to ensure these products do not have any safety-related defects. Ms. Kotula-Cook said that MDI will be contacting us directly for more information about Standard No. 213 and these responsibilities. We are returning the copy of MDI's letter you provided us. If you have any questions, please call Ms. Fujita at (202) 366-2992. Sincerely, Paul Jackson Rice Chief Counsel";