Part 1107 — Exemption Requests and Substantial Equivalence Reports
Current through Sep 8, 2026
Authority: 21 U.S.C. 371, 374, 387e(j), 387i, 387j; Pub. L. 117-103, 136 Stat. 49.
Source: 76 FR 38974, July 5, 2011, unless otherwise noted.
Sections
- § 1107.1 Exemptions.
- § 1107.3 Recordkeeping.
- § 1107.10 Scope.
- § 1107.12 Definitions.
- § 1107.16 Submission of a substantial equivalence report.
- § 1107.18 Required content and format of an SE Report.
- § 1107.19 Comparison information.
- § 1107.20 Amendments.
- § 1107.22 Withdrawal by applicant.
- § 1107.24 Change in ownership of an SE Report.
- § 1107.40 Communications between FDA and applicants.
- § 1107.42 Review cycles.
- § 1107.44 FDA action on an SE Report.
- § 1107.46 Issuance of an order finding a new tobacco product substantially equivalent.
- § 1107.48 Issuance of an order denying marketing authorization.
- § 1107.50 Rescission of order.
- § 1107.58 Record retention.
- § 1107.60 Confidentiality.
- § 1107.62 Electronic submission.