Search Results "FDA: Food and Drug Administration"

• Federal Documents > Preamble to Standards
  A. Purpose and Legal Authority

  Section 510 of the Rehabilitation Act charges the Access Board, in consultation with the Commissioner of the Food and Drug Administration, with issuing standards that set forth the minimum...

• Rulemaking Process Documents > NPRMS
  B. Patient Protection and Affordable Care Act and Section 510 of the Rehabilitation Act

  Section 510 of the Rehabilitation Act (29 USC 794f) requires the Access Board, in consultation with the Commissioner of the Food and Drug Administration, to issue standards that contain...

• Rulemaking Process Documents > Committee Activity and Reports
  2.5.1 U.S. Food and Drug Administration

  Food and Drug Administration FDA is responsible for ensuring that medical devices that manufacturers want to introduce into commerce in the U.S. are safe and effective for their intended...

• Rulemaking Process Documents > Committee Activity and Reports
  2.5.2.3 FDA Standards

  2.5.2.3 FDA Standards The FDA maintains a list of recognized consensus standards on their web site,P which includes standards from IEC, ISO, and other organizations. Manufacturers...

• Rulemaking Process Documents > NPRMS
  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...

• Rulemaking Process Documents > Committee Activity and Reports
  4.3.1 Overview of Imaging Equipment and Regulatory Environment

  Food and Drug Administration (FDA) regulates the majority of diagnostic imaging equipment as Class II medical devices, which need pre-market approval by FDA (510(k) clearance) prior to being...