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US law
Federal (United States)
Regulations
Title 21 CFR — Food and Drugs
Chapter I — FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
Part 1107 — EXEMPTION REQUESTS AND SUBSTANTIAL EQUIVALENCE REPORTS
Subpart C — Substantial Equivalence Reports
Federal (United States) · Regulations
Subpart C — Substantial Equivalence Reports
6 sections
6 sections
21 C.F.R. § 1107.16
Submission of a substantial equivalence report.
21 C.F.R. § 1107.18
Required content and format of an SE Report.
21 C.F.R. § 1107.19
Comparison information.
21 C.F.R. § 1107.20
Amendments.
21 C.F.R. § 1107.22
Withdrawal by applicant.
21 C.F.R. § 1107.24
Change in ownership of an SE Report.
Subpart C — Substantial Equivalence Reports | Federal (United States) Regulations | Justis AI