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U.S. Department of Health and Human Services

About FDA

Assist the Access Board in Developing Accessibility Standards

Description: Consult with the Architectural and Transportation Barriers Compliance Board (the Access Board) as the Access Board creates technical criteria for medical device accessibility to advance human welfare and provide the disabled with appropriate and equal access to the medical care they need.

Accomplishment: Provisions of Section 4203 of the Patient Protection and Affordable Care Act (ACA) require the Architectural and Transportation Barriers Compliance Board (U.S. Access Board), in consultation with the Food and Drug Administration (FDA), to issue accessibility standards for medical diagnostic equipment (MDE) to accommodate adults with disabilities. To maximize their health and wellbeing, persons with disabilities require access to the same range of MDE as individuals without disabilities, including examination tables, examination chairs, weight scales, mammography equipment, and diagnostic imaging equipment. To meet the ACA Section 4203 mandate, the U.S. Access Board issued a Notice of Proposed Rulemaking in the Federal Register (February 9, 2012) proposing MDE accessibility standards for adults with disabilities. At its January 11, 2012 meeting, the Access Board voted to establish an advisory committee to make recommendations to the Board on issues raised by comments on and questions about the proposed MDE standards. After soliciting nominations for committee membership, the U.S. Access Board empanelled the Medical Diagnostic Equipment Accessibility Standards Advisory Committee (the MDE Advisory Committee), comprised of individuals from 24 organizations representing a range of stakeholders and ex officio members from the FDA, Department of Justice, and the Department of Veterans Affairs. The MDE Advisory Committee met from September 2012 through May 2013. Much of the Committee work occurred within five Subcommittees that addressed major categories of MDE: Examination Tables and Chairs; Stretchers; Diagnostic Imaging Equipment; Mammography Equipment; and Weight Scales. In June 2013, Advisory Committee members agreed upon 54 recommendations for the MDE standards. A final recommendations report was issued on December 6, 2013.

Milestone DescriptionMilestone DateMilestone StatusMilestone Completion Date

A. Work with the Access Board to determine priority medical devices to establish technical accessibility standards for in the next 18 months

9/9/2010

Completed 9/9/2010

B. Conduct gap analysis of recognized standards to determine which currently recognized voluntary consensus standards the Access Board may leverage in developing its standards

11/30/2010

Completed 11/30/2010

C. Determine applicable barriers and necessary design criteria to address those barriers

2/1/2011

Completed 2/1/2011

D. Brief Dr. Hamburg about the devices to which the criteria will apply, the results of the gap analysis, future considerations, and timeframe for development of the standards

12/16/2010

Completed 12/16/2010

E. Brief the Department of Health and Human Services (HHS) with the Access Board about the results of the gap analysis, existing standards, and new standards to be developed

5/31/2011

Completed 12/6/2011

F. Publish proposed rule describing technical criteria

6/30/2011

Completed 2/9/2012

G. Publish final report

3/1/2012

Completed 12/6/2013

Key Projects Legend

Milestone StatusDefinition
Not Yet StartedWork for specific milestone has not yet been started.
CompletedMilestone and/or overall project is completed.
On TrackMilestone - On track for completion by milestone deadline. Quarter status - Project is on track for completion based on overall milestone status.
On HoldMilestone - On hold, but deadline for completion has not passed. Quarter status - Project is on hold, based on overall milestone status.
DelayedMilestone - Delayed as it has not been completed and deadline has passed. Quarter status - Project is delayed based on overall milestone status.

Glossary

Note: The data provided on this website is produced on an ongoing basis for performance management purposes and is subject to change due to updates of preliminary estimates, corrections, or other reasons. In addition, FDA may change the type or amount of data provided on this website at any time. Information marked as "Completed" may include measures and/or key projects for which activities are ongoing but no longer tracked as part of FDA-TRACK.