14 CFR Part 382 Nondiscrimination on the Basis of Disability in Air Travel (Air Carrier Access Act): Preamble and Section-by-Section Analysis (with amendments issued through July 2010)

3. Testing and Labeling of Electronic Respiratory Assistive Devices

In the Oxygen NPRM, we proposed that a U.S. carrier that conducts passenger-carrying service other than an on-demand air taxi operator perform the necessary evaluation and testing of a ventilator, respirator, CPAP machine or FAA-approved POC to determine if the device causes interference with the navigation or communication systems of each model of aircraft the U.S. carrier operates. We also proposed requiring a foreign carrier that conducts passenger-carrying service other than an on-demand air taxi operator to perform the necessary evaluation and testing of these devices to ascertain whether such device can be used safely by passengers during a flight on each aircraft that the foreign carrier operates on flights to and from the U.S.

Industry commenters as well as some consumers said that the burden of testing should be shifted away from the carriers. The Air Transport Association and other industry commenters proposed that carriers only be required to permit the use of an electronic respiratory assistive device that has been tested and marked as approved by RTCA, Inc. (formerly the Radio Technical Commission for Aeronautics). These commenters argued that if carriers have the option of refusing to carry any device that is not tested and marked as approved by the RTCA then the device manufacturers would have an incentive to test their devices and produce safety testing results for the carriers to review. Other commenters suggested that the device manufacturers and the aircraft manufacturers should be required to conduct the testing and then label the device as approved for use aboard aircraft, as manufacturers have the greatest incentive to test devices. Industry commenters also requested that the FAA create a generic safety standard for testing respiratory devices as well as a uniform labeling system for all approved devices to cut down on confusion by carriers and passengers.

Having considered all of these comments, the Department is persuaded that responsibility for electromagnetic interference testing of the four types of electronic respiratory assistive devices covered in the Oxygen NPRM should be borne by the manufacturers of such devices rather than the carriers. However, this regulation does not mandate manufacturer testing. The FAA is considering whether to issue an NPRM in which the agency would propose to require manufacturers that want to market their ventilators, respirators, CPAP machines, and FAA-approved POCs for passenger use on aircraft to test those devices against FAA-prescribed performance standards and affix a label to each device stating that it meets the applicable standards prescribed in the federal aviation regulations. If the FAA decides to issue such an NPRM, the NPRM would clarify that those manufacturers that do not intend to market their devices for use on aircraft would be under no obligation to conduct any testing and would not be permitted to affix a label indicating FAA approval. The manufacturers that want to market such devices for use on aircraft but whose devices fail to meet the performance standards would also not be permitted to affix a label indicating FAA approval. Moreover, the FAA will consider whether to include other proposals in that NPRM, including specifying how a carrier would "verify" whether the aforementioned electronic respiratory assistive devices meet FAA performance standards.

In this rulemaking, we are strongly encouraging manufacturers that market their electronic respiratory assistive devices for use by passengers on aircraft to test their devices to determine whether they meet FAA electromagnetic and radio frequency interference emission standards set forth in FAA Advisory Circular No. 91.21-1B, and if they do so, to label the devices as FAA-compliant. The label should indicate that the device is approved for air travel (i.e., the device can be used safely during all phases of travel). The FAA generally prohibits the operation of portable electronic devices aboard U.S. registered civil aircraft while operating under instrument flight rules. See 14 CFR 91.21. However, the FAA through its Advisory Circular No. 91.21-1B allows U.S. carriers to permit passengers to use onboard the aircraft specified portable electronic devices (including the four types of respiratory devices addressed in this rulemaking) that have been tested by the manufacturer and found to not exceed the maximum level of radiated radio frequency interference as described in section 21, Category M of RTCA Document (DO)-160 while in all modes of operation, without any further testing by the carrier to establish compliance with this performance standard. It is worth noting that the FAA does not have a prohibition on the operation of portable electronic devices aboard civil aircraft registered in a country other than the United States.

This rule requires U.S. carriers to permit individuals to use electronic respiratory assistive devices in the passenger cabin so long as the devices have been tested and labeled by their manufacturer(s) as meeting the applicable FAA requirements for medical portable electronic devices as described in FAA Advisory Circular No. 91.21-1B (the FAA-approved POCs would also be subject to the requirements of Special Federal Aviation Regulation 106) and the device can be stowed consistent with FAA cabin safety requirements. At present, a label indicating that the device complies with RTCA standards meets FAA requirements and need not specifically state that the device is FAA approved.

The final rule also requires foreign carriers to permit individuals to use electronic respiratory assistive devices in the passenger cabin if certain conditions are met. First, the device must have been tested and labeled by its manufacturer as meeting the requirements for medical portable electronic devices set by the foreign carrier’s government. If the foreign carrier’s government does not have applicable requirements, then the carrier may elect to apply requirements for medical portable electronic devices set by the FAA for U.S. carriers. It would be a violation of our rules for a foreign carrier to prohibit a passenger from using his/her ventilator, respirator, CPAP machine, or POC in the passenger cabin because its government has not issued applicable rules on the testing or labeling of electronic respiratory assistive devices. We encourage foreign carriers to apply FAA requirements for medical portable electronics where the foreign carriers’ government has not issued applicable rules. Otherwise, it is not clear how the foreign carrier can be assured that the electronic respiratory assistive device that it is accepting for use in the cabin is safe. Also, the electronic respiratory assistive device must be stowed and used in the passenger cabin consistent with any applicable U.S. regulations and the regulations of the carrier’s government.

We expect that both U.S. and foreign carriers will inspect the device label at the departure gate to ensure that it is labeled by the manufacturer in accordance with the applicable regulations. U.S. carriers’ internal procedures must ensure that approved devices bearing labels indicating that they meet the FAA requirements are accepted. For foreign carriers, devices containing labels indicating that the device meets requirements set by the foreign carrier’s government or, if no such requirement exists, the requirements for medical portable electronics set by the FAA for U.S. carriers, should be accepted.