Direct Final Rulemaking Procedures and Implementation Process

What You Need to Know? 👇

What is FDA’s direct final rulemaking process and when is it used?

Direct final rulemaking is an expedited process FDA uses for routine or noncontroversial rules when no significant adverse comments are anticipated. It’s used for minor regulatory changes, technical standards updates, compliance date extensions, and legislative mandate incorporations.

How long does the FDA direct final rule process take from publication to implementation?

The process takes a maximum of 135 days: 75 days for public comment, 30 days for FDA to review comments and confirm effective date, and 30 days before the rule takes effect after confirmation notice publication.

What constitutes a “significant adverse comment” that would withdraw a direct final rule?

A significant adverse comment explains why the rule would be inappropriate, challenges its underlying premise or approach, or demonstrates it would be ineffective without changes. Frivolous, insubstantial, or out-of-scope comments don’t qualify as significant adverse comments.

What happens if FDA receives significant adverse comments on a direct final rule?

FDA withdraws the direct final rule within 30 days after the comment period ends and publishes a notice. The companion proposed rule then proceeds through standard notice-and-comment rulemaking procedures using the received comments.

Can FDA partially implement a direct final rule if only some sections receive adverse comments?

Yes, if a significant adverse comment applies to a severable part of the rule, FDA may adopt the remaining portions that weren’t subject to significant adverse comments while withdrawing only the problematic sections.

What is the companion proposed rule published alongside a direct final rule?

The companion proposed rule is published simultaneously in the Federal Register as a backup. It serves as the proposed rule for standard notice-and-comment procedures if the direct final rule must be withdrawn due to significant adverse comments.

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What You Need to Do 👇

Recommended Actions

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

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Related references and norms 📂

No specific norms or standards are referenced in this guidance.

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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 ID: e36f9a5d5a1e44d3e6f85b3e632222ce