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

Other relevant federal rules and guidance documents

As discussed above, DOJ and the Department of Health and Human Services issued a guidance document for health care providers regarding their responsibilities to make their services and facilities accessible to individuals with mobility disabilities under the ADA and Section 504 of the Rehabilitation Act. DOJ also issued an ANPRM announcing that it was considering amending its regulations implementing Titles II and III of the ADA to ensure that equipment and furniture used in programs and services provided by state and local governments and by public accommodations are accessible to individuals with disabilities. See 75 FR 43452 (July 26, 2010). Among other things, the ANPRM stated that DOJ was considering amending its ADA regulations to specifically require health care providers to acquire accessible medical equipment and that it would consider adopting the standards issued by the Access Board. DOJ also indicated its intention to include in its ADA regulations scoping requirements that specify the minimum number of types of accessible medical equipment required in different types of health care facilities.

The Access Board worked closely with the FDA-CDRH in developing the proposed standards. The FDA-CDRH may develop a guidance document to inform manufacturers how it intends to apply its regulatory authority to clearance or approval of medical devices addressed in the Access Board’s standards. If the FDA-CDRH develops such a guidance document, it will provide the public notice and opportunity to comment on a draft of the guidance document in accordance with its procedures for issuing guidance documents. See 21 CFR 10.115.