The substance of the policy is essentially unchanged between the draft and final versions. The two circumstances for opening a Type VII VMF, the eligibility criteria, VMF contents, periodic reporting requirements, and all six R&D/risk-review examples are the same in both versions. The differences below are mostly administrative or legal-status items, with a few clarifying wording changes.
1. Legal Status — Now Effective Guidance, Not a Proposal
- The draft was explicitly labeled "for comment purposes only" and was not final.
- The final version is issued as a Level 1 Final Guidance under 21 CFR 10.115(g)(2) & (3), meaning it is for immediate implementation with no further comment period required before taking effect.
- A Guidance History table was added to the final version, documenting the timeline: Draft (January 2025) → Final (August 2026).
2. Contact Information Changed
- Draft contact: Lynne Boxer, Center for Veterinary Medicine, direct phone (240-402-0611) and email, located at 7500 Standish Place, Rockville, MD 20855.
- Final contact: generic inbox AskCVM@fda.hhs.gov, with the CVM address updated to 5001 Campus Dr., College Park, MD 20740.
- Industry should update internal records and correspondence routing accordingly.
3. Statutory Citations Tightened and Expanded
- User fee provisions now explicitly cite "sections 739 and 740 of the FD&C Act" alongside the existing U.S.C. citations. The draft cited only the U.S.C. sections. This appears in both:
- Section III.C (VMF user fees)
- Section IV.C (investigational file user fees/waivers)
- The investigational-use labeling restriction now cites "section 512(j) of the FD&C Act" in addition to 21 U.S.C. § 360b(j).
- These are clarifying additions rather than new substantive obligations, but they're useful if citing the guidance in a regulatory submission.
4. Minor Wording Clarifications (No Substantive Change)
- "we would not expect you to establish an investigational file but instead open a Type VII VMF in cases where you are requesting a risk review" — "in cases" added.
- "after considering relevant data and information" — "relevant" added.
- Example 1 (R&D section): "which cell type is most appropriate" — "type" added.
5. Title and Cover Page Framing
- Draft cover page: "Draft Guidance — This document is being distributed for comment purposes only."
- Final cover page: simply "Guidance for Industry," dated August 2026.
The differences are generated by AI models and can contain mistakes. Please double-check the content.