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

F. Consultation with Food and Drug Administration

The Commissioner of the Food and Drug Administration has designated the Director of the Center for Devices and Radiological Health (FDA-CDRH) to consult with the Access Board on the development of standards for accessible medical diagnostic equipment. The Access Board has 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.