Recommendations on Standards for the Design of Medical Diagnostic Equipment for Adults with Disabilities, Advisory Committee Final Report

7.4 Legal and Regulatory Considerations

The Americans with Disabilities Act and Section 504 of the Rehabilitation Act of 1973 require that covered medical care providers ensure that medical care and services are provided to persons with disabilities in a nondiscriminatory manner. These federal laws also require that persons with disabilities be given an equal opportunity to participate in and benefit from the providers’ medical services, including access to the facilities where services are provided and to the equipment medical practitioners’ use for diagnostic and other services. Accessible medical equipment is required in order to meet this nondiscrimination obligation and eliminate the barriers that inaccessible equipment can create for persons with disabilities. In cases where imaging equipment is fixed, it must meet the requirements of the 2010 ADA Standards. The requirements imposed by these Standards, which are enforceable under the ADA, were only peripherally considered during Advisory Committee’s deliberations. Regulations implementing these federal laws do not currently include specific technical requirements for the accessibility of non-fixed medical equipment, although steps are underway by the Department of Justice (DOJ) to propose specific ADA technical standards for medical equipment.

DOJ’s future work on medical equipment will be broader in scope than the Access Board’s work as it will not be limited to diagnostic medical equipment. In addition, later DOJ regulations may lay out limited circumstances where “equivalent facilitation” is permissible under the Americans with Disabilities Act. For example, later regulations may discuss possible limited circumstances in which alternative means may be used to provide equivalent or greater access to medical equipment through the use of ancillary equipment, lifts, or architectural modifications in an interim period before medical equipment with integrated accessible features is fully available

FDA may review imaging equipment that has been modified to make it accessible when a manufacturer wants to introduce it into commercial distribution in the U.S. for the first time, or if a marketed device has been changed in a way that could significantly affect the device’s safety or effectiveness. FDA reviews most imaging equipment as Class II medical devices because they typically are substantially equivalent to other equipment that is already approved and on the market. If manufacturers make substantial changes to or new claims about Class II devices, then they might need to submit materials to FDA to show that the modified product meets the standard of “substantial equivalence”.^NN If the manufacturer states in its labeling that the device is “accessible” because it conforms to the new standards, this would be a marketing claim that FDA would review to verify that the claim is accurate, for example, by verifying the device’s range of height adjustability. Only very few technologically innovative products that present high levels of risk and have no substantially equivalent predicate on the market are required to go through FDA’s more stringent Class III device premarket approval (PMA) process to assure their safety and effectiveness.^OO In addition, FDA exempts several categories of common medical devices, including most radiological tables, examination tables, and scales, from any FDA clearance or approval requirement.

Notes

^NN It is important to note that the ADA concept of “equivalent facilitation” and the FDA concept of “substantial equivalence” are not identical or interchangeable.

^OO It is extremely unlikely that modifying any imaging equipment to make it accessible would trigger a premarket approval process.