Code of Federal Regulations · Section

§ 26.31 — Purpose

21 C.F.R. § 26.31

This section was removed from the CFR

Removed as of 2026-03-25. The text below is the last known version.

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(a) The purpose of this subpart is to specify the conditions under which a party will accept the results of quality system-related evaluations and inspections and premarket evaluations of the other party with regard to medical devices as conducted by listed conformity assessment bodies (CAB's) and to provide for other related cooperative activities.

(b) This subpart is intended to evolve as programs and policies of the parties evolve. The parties will review this subpart periodically, in order to assess progress and identify potential enhancements to this subpart as Food and Drug Administration (FDA) and European Community (EC) policies evolve over time.

21 C.F.R. § 26.32

Authorizing Statute

Requirements of labeling; placement, form, and contents of statement of quantity; supplemental statement of quantity
15 U.S.C. § 1453
Disclosure of confidential information generally
18 U.S.C. § 1905
Regulations
42 U.S.C. § 216
Public information; agency rules, opinions, orders, records, and proceedings
5 U.S.C. § 552
Definitions; generally
21 U.S.C. § 321