Standard: HHS - 21 CFR PART 25


This standard is available with a subscription to IHS Standards Expert.

About IHS Standards Expert

IHS Standards Expert subscription, simplifies and expedites the process for finding and managing standards by giving you access to standards from over 370 standards developing organizations (SDOs).

  • Maximize product development and R&D with direct access to over 1.6 million standards
  • Discover new markets: Identify unmet needs and discover next-generation technologies
  • Improve quality by leveraging consistent standards to meet customer and market requirements
  • Minimize risk: Mitigate liability and better understand compliance regulations
  • Boost efficiency: Speed up research, capture and reuse expertise
For additional product information, visit the IHS Standards Expert page.

For more information or a custom quote, visit the IHS Contact Us page for regional contact information.


The National Environmental Policy Act of 1969 (NEPA), as amended, directs that, to the fullest extent possible, the policies, regulations, and public laws of the United States shall be interpreted and administered in accordance with the policies set forth in NEPA. All agencies of the Federal Government shall comply with the procedures in section 102(2) of NEPA except where compliance would be inconsistent with other statutory requirements. The regulations in this part implement section 102(2) of NEPA in a manner that is consistent with FDA’s authority under the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act. This part also supplements the regulations for implementing the procedural provisions of NEPA that were published by the Council on Environmental Quality (CEQ) in 40 CFR parts 1500 through 1508 and the procedures included in the ‘‘HHS General Administration Manual, part 30: Environmental Protection’’ (45 FR 76519 to 76534, November 19, 1980).

Organization: Food and Drug Administration (Medical Products Quality Assurance)
Document Number: 21 cfr part 25
Publish Date: 2016-04-01
Page Count: 13
Available Languages: EN
DOD Adopted: NO
ANSI Approved: NO
Most Recent Revision: YES
Current Version: YES
Status: Active

Document History

Document # Change Type Update Date Revision Status
21 CFR PART 25 Change Type: COMPLETE REVISION Update Date: 2017-04-01 Status: ACTV
21 CFR PART 25 Change Type: STCH Update Date: 2014-04-01 Status: INAC
21 CFR PART 25 Change Type: COMPLETE REVISION Update Date: 2015-04-01 Status: ACTV