Source: https://www.law.cornell.edu/cfr/text/21/26.9?quicktabs_7=1
Timestamp: 2015-09-02 14:50:59
Document Index: 91934395

Matched Legal Cases: ['art 26', '§ 321', '§ 331', '§ 351', '§ 352', '§ 355', '§ 360', '§ 360', '§ 360', '§ 360', '§ 360', '§ 360', '§ 360', '§ 360', '§ 360', '§ 360', '§ 360', '§ 360', '§ 371', '§ 374', '§ 381', '§ 382', '§ 383', '§ 393']

21 CFR 26.9 - Equivalence determination. | US Law | LII / Legal Information Institute
CFR › Title 21 › Chapter I › Subchapter A › Part 26 › Subpart A › Section 26.9 21 CFR 26.9 - Equivalence determination.
Equivalence determination.
Equivalence is established by having in place regulatory systems covering the criteria referred to in appendix D of this subpart, and a demonstrated pattern of consistent performance in accordance with these criteria. A list of authorities determined as equivalent shall be agreed to by the Joint Sectoral Committee at the end of the transition period, with reference to any limitation in terms of inspection type (e.g., postapproval or preapproval) or product classes or processes.
The parties will document insufficient evidence of equivalence, lack of opportunity to assess equivalence or a determination of nonequivalence, in sufficient detail to allow the authority being assessed to know how to attain equivalence.
U.S. Code: Title 21 - FOOD AND DRUGS§ 321 - Definitions; generally§ 331 - Prohibited acts§ 351 - Adulterated drugs and devices§ 352 - Misbranded drugs and devices§ 355 - New drugs§ 360 - Registration of producers of drugs or devices§ 360b - New animal drugs§ 360c - Classification of devices intended for human use§ 360d - Performance standards§ 360e - Premarket approval§ 360e-1§ 360f - Banned devices§ 360g - Judicial review§ 360h - Notification and other remedies§ 360i - Records and reports on devices§ 360j - General provisions respecting control of devices intended for human use21 U.S. Code § -§ 360m - Accredited persons§ 371 - Regulations and hearings§ 374 - Inspection§ 381 - Imports and exports§ 382 - Exports of certain unapproved products§ 383 - Office of International Relations§ 393 - Food and Drug Administration