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Regulations last checked for updates: May 14, 2025
Title 21 - Food and Drugs last revised: May 12, 2025
All Titles
Title 21
Chapter I
Part 807
Subpart E - Subpart E—Premarket Notification Procedures
§ 807.81 - When a premarket notification submission is required.
§ 807.85 - Exemption from premarket notification.
§ 807.87 - Information required in a premarket notification submission.
§ 807.90 - Format of a premarket notification submission.
§ 807.92 - Content and format of a 510(k) summary.
§ 807.93 - Content and format of a 510(k) statement.
§ 807.94 - Format of a class III certification.
§ 807.95 - Confidentiality of information.
§ 807.97 - Misbranding by reference to premarket notification.
§ 807.100 - FDA action on a premarket notification.
authority:
21 U.S.C. 321
,
331
,
351
,
352
,
360
,
360
c,
360
e,
360
e-4,
360
i,
360
j,
360
bbb-8b,
371
,
374
,
379k
,
381
,
393
;
42 U.S.C. 264
,
271
source:
42 FR 42526, Aug. 23, 1977, unless otherwise noted.
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