36 CFR Part 1195 Proposed Accessibility Standards for Medical Diagnostic Equipment NPRM - Preamble

Medical Device Manufacturers

If DOJ amends its ADA regulations as announced in the ANPRM, small medical device manufacturers may have an economic incentive to produce accessible products that conform to the standards for health care providers who need to acquire accessible medical diagnostic equipment. The size of the economic incentive will depend on the amount of accessible medical diagnostic equipment health care providers need to acquire and the manufacturers’ incremental costs to design or redesign and manufacture accessible products that conform to the standards.

Many medical device manufacturers currently incorporate accessible features in some of their products such as patient support surfaces that are height adjustable, transfer and positioning supports, and scales designed for use by patients seated in a wheelchair. The incremental costs for manufacturers to conform these products to the standards are expected to be small because the features may already meet or closely meet the standards. The incremental costs may be greater for manufacturers that do not currently incorporate accessible features in their products but plan to do so in future designs or redesigns of their products. The incremental costs to design or redesign and manufacture accessible products that conform to the standards will be incurred voluntarily by manufacturers that choose to produce them for health care providers who need to acquire accessible medical diagnostic equipment. Some manufacturers may choose not to design or redesign and manufacture accessible products that conform to the standards, or may produce accessible products with less market appeal than that of their competitors, thereby losing market share and incurring losses. These economic impacts are not regulatory costs and are not generally social costs because for the most part, one manufacturer’s loss is another manufacturer’s gain.

The preamble requests comments on the incremental costs to design or redesign and manufacture products that conform to the technical criteria in the proposed standards, as well as alternative and additional technical criteria that the Access Board is considering. The Access Board will consider the information provided in the comments when preparing the final standards, and will provide an analysis of the incremental costs with the final standards.