Title 21

PART 26 SUBPART B

Subpart B - Specific Sector Provisions for Medical Devices

• 5 U.S.C. 552; 15 U.S.C. 1453, 1454, 1455; 18 U.S.C. 1905; 21 U.S.C. 321, 331, 351, 352, 355, 360, 360b, 360c, 360d, 360e, 360f, 360g, 360h, 360i, 360j, 360l, 360m, 371, 374, 381, 382, 383, 393; 42 U.S.C. 216, 241, 242l, 262, 264, 265.
• 63 FR 60141, Nov. 6, 1998, unless otherwise noted.

21:1.0.1.1.20.2.63.1	SECTION 26.31	26.31 Purpose.
21:1.0.1.1.20.2.63.2	SECTION 26.32	26.32 Scope.
21:1.0.1.1.20.2.63.3	SECTION 26.33	26.33 Product coverage.
21:1.0.1.1.20.2.63.4	SECTION 26.34	26.34 Regulatory authorities.
21:1.0.1.1.20.2.63.5	SECTION 26.35	26.35 Length and purpose of transition period.
21:1.0.1.1.20.2.63.6	SECTION 26.36	26.36 Listing of CAB's.
21:1.0.1.1.20.2.63.7	SECTION 26.37	26.37 Confidence building activities.
21:1.0.1.1.20.2.63.8	SECTION 26.38	26.38 Other transition period activities.
21:1.0.1.1.20.2.63.9	SECTION 26.39	26.39 Equivalence assessment.
21:1.0.1.1.20.2.63.10	SECTION 26.40	26.40 Start of the operational period.
21:1.0.1.1.20.2.63.11	SECTION 26.41	26.41 Exchange and endorsement of quality system evaluation reports.
21:1.0.1.1.20.2.63.12	SECTION 26.42	26.42 Exchange and endorsement of product evaluation reports.
21:1.0.1.1.20.2.63.13	SECTION 26.43	26.43 Transmission of quality system evaluation reports.
21:1.0.1.1.20.2.63.14	SECTION 26.44	26.44 Transmission of product evaluation reports.
21:1.0.1.1.20.2.63.15	SECTION 26.45	26.45 Monitoring continued equivalence.
21:1.0.1.1.20.2.63.16	SECTION 26.46	26.46 Listing of additional CAB's.
21:1.0.1.1.20.2.63.17	SECTION 26.47	26.47 Role and composition of the Joint Sectoral Committee.
21:1.0.1.1.20.2.63.18	SECTION 26.48	26.48 Harmonization.
21:1.0.1.1.20.2.63.19	SECTION 26.49	26.49 Regulatory cooperation.
21:1.0.1.1.20.2.63.20	SECTION 26.50	26.50 Alert system and exchange of postmarket vigilance reports.
21:1.0.1.1.20.2.63.21.6	APPENDIX Appendix A	Appendix A to Subpart B of Part 26 - Relevant Legislation, Regulations, and Procedures.
21:1.0.1.1.20.2.63.21.7	APPENDIX Appendix B	Appendix B to Subpart B of Part 26 - Scope of Product Coverage
21:1.0.1.1.20.2.63.21.8	APPENDIX	Appendixes C-F to Subpart B of Part 26 [Reserved]

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