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Regulations last checked for updates: Nov 24, 2024
Title 21 - Food and Drugs last revised: Nov 21, 2024
All Titles
Title 21
Chapter I
Part 26
Subpart B - Subpart B—Specific Sector Provisions for Medical Devices
§ 26.31 - Purpose.
§ 26.32 - Scope.
§ 26.33 - Product coverage.
§ 26.34 - Regulatory authorities.
§ 26.35 - Length and purpose of transition period.
§ 26.36 - Listing of CAB's.
§ 26.37 - Confidence building activities.
§ 26.38 - Other transition period activities.
§ 26.39 - Equivalence assessment.
§ 26.40 - Start of the operational period.
§ 26.41 - Exchange and endorsement of quality system evaluation reports.
§ 26.42 - Exchange and endorsement of product evaluation reports.
§ 26.43 - Transmission of quality system evaluation reports.
§ 26.44 - Transmission of product evaluation reports.
§ 26.45 - Monitoring continued equivalence.
§ 26.46 - Listing of additional CAB's.
§ 26.47 - Role and composition of the Joint Sectoral Committee.
§ 26.48 - Harmonization.
§ 26.49 - Regulatory cooperation.
§ 26.50 - Alert system and exchange of postmarket vigilance reports.
Appendix Appendix A - Appendix A to Subpart B of Part 26—Relevant Legislation, Regulations, and Procedures.
Appendix Appendix B - Appendix B to Subpart B of Part 26—Scope of Product Coverage
Appendix - Appendixes C-F to Subpart B of Part 26 [Reserved]
authority:
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
,
360
b,
360
c,
360
d,
360
e,
360
f,
360
g,
360
h,
360
i,
360
j,
360
l,
360
m,
371
,
374
,
381
,
382
,
383
,
393
;
42 U.S.C. 216
,
241
,
242l
,
262
,
264
,
265
source:
63 FR 60141, Nov. 6, 1998, unless otherwise noted.
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