36 CFR Part 1195 Standards for Accessible Medical Diagnostic Equipment - Preamble

B. Chapter 2: Scoping (Section-by-Section Analysis)

In the final rule, Chapter 2 establishes that the enforcing authority will determine the number and types of diagnostic equipment to which the MDE Standards will apply. The Access Board did not receive any comments regarding Chapter 2 as written; however, several commenters expressed concern regarding the ability of certain types of diagnostic equipment to comply with the MDE Standards. These concerns, discussed above in Section IV.A.1. (Significant Changes – General Exception), resulted in the addition of the M201.2 General Exception, described below. In addition, the Access Board made one editorial change to M201.1.

M201 General (Section-by-Section Analysis)

This is an introductory section.

M201.1 Enforcing Authority (Section-by-Section Analysis)

The MDE NPRM proposed to explain that the enforcing authority would specify the minimum number of types of accessible diagnostic equipment that would be required to comply with the MDE Standards. There were no public comments regarding this provision. The Access Board has decided to make an editorial change to this section to clarify that the enforcing authority will specify the minimum number and types of accessible diagnostic equipment that will be required to comply with the MDE Standards.

M201.2 General Exception (Section-by-Section Analysis)

The MDE NPRM did not propose a general exception for diagnostic equipment that was not capable of meeting the MDE Standards. As described in Section IV.A.1. (Significant Changes – General Exception), the Access Board received public comments and MDE Advisory Committee recommendations regarding certain types of diagnostic equipment that are unable to meet all of the requirements in the MDE Standards. In response, the Access Board has added a new provision excepting diagnostic equipment from compliance with an applicable requirement in the MDE Standards in the rare circumstance where compliance would alter diagnostically required structural or operational characteristics of the equipment, and would prevent the use of the equipment for its intended diagnostic purpose. Any equipment falling under this exception must comply with the provision(s) in question to the maximum extent practicable, and must fully comply with all other provisions not utilizing this exception.