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Direct Final Rulemaking Procedures and Implementation Process

This guidance explains FDA's procedures for direct final rulemaking, which is used to expedite the issuance of routine or noncontroversial rules. It outlines when and how FDA will employ this process to streamline regulatory updates.

  1. Monitor Federal Register for direct final rules relevant to your products or operations
  2. Establish internal process to review direct final rules within the 75-day comment period
  3. Prepare response mechanism for submitting comments if necessary
  4. Track implementation dates of direct final rules that become effective
  5. Update internal procedures and documentation when direct final rules affecting your operations become effective
  6. Maintain awareness of which regulatory changes are implemented through direct final rule process versus standard rulemaking
  7. Consider participating in the comment process if the direct final rule impacts your operations significantly

Key Considerations

Other considerations

  • Direct final rule process is used when FDA does not anticipate significant adverse comments
  • 75-day comment period is typically allowed after Federal Register publication
  • Significant adverse comments must explain why the rule would be inappropriate, challenge its premise, or indicate ineffectiveness
  • If significant adverse comments are received, the direct final rule will be withdrawn within 30 days after comment period
  • Without significant adverse comments, rule becomes effective within 135 days of Federal Register publication
  • Applicable for:
    • Minor substantive changes to regulations
    • Incorporation of latest technical standards
    • Extensions of compliance dates
    • Direct incorporation of new legislation mandates
    • Other noncontroversial rules

      No specific norms or standards are referenced in this guidance.


Original guidance

  • Direct Final Rulemaking Procedures and Implementation Process
  • HTML
  • Issue date: 1997-11-20
  • Last changed date: 2024-09-04
  • Status: FINAL
  • Official FDA topics: Radiation-Emitting Products, Tobacco, Medical Devices, Food & Beverages, Dietary Supplements, Drugs, Animal & Veterinary, Biologics, Cosmetics, Administrative / Procedural
  • ReguVirta summary file ID: e36f9a5d5a1e44d3e6f85b3e632222ce
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