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This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.
This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].
It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly. More limitations on accuracy are described at the GPO site.
§ 321 - Definitions; generally
§ 331 - Prohibited acts
§ 334 - Seizure
§ 342 - Adulterated food
§ 343 - Misbranded food
§ 351 - Adulterated drugs and devices
§ 352 - Misbranded drugs and devices
§ 360e - Premarket approval
§ 360i - Records and reports on devices
§ 360k - State and local requirements respecting devices
§ 361 - Adulterated cosmetics
§ 362 - Misbranded cosmetics
§ 371 - Regulations and hearings
Title 21 published on 20-Feb-2018 03:48
The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 800 after this date.
The Food and Drug Administration (FDA) is proposing to implement regulations regarding internal agency supervisory review of certain decisions related to devices regulated by the Center for Devices and Radiological Health (CDRH) under the Federal Food, Drug, and Cosmetic Act (FD&C Act) to conform to the applicable provisions in the Food and Drug Administration Safety and Innovation Act (FDASIA) and the 21st Century Cures Act (Cures Act). FDA is taking this action to codify the procedures and timeframes for supervisory review of significant decisions pertaining to devices within CDRH. FDA is also proposing regulations to provide new procedural requirements for requesting internal agency supervisory review within CDRH of other types of decisions made by CDRH not addressed in FDASIA and the Cures Act. This action is also part of FDA's implementation of Executive Orders (EOs) 13771 and 13777. Under these EOs, FDA is comprehensively reviewing existing regulations to identify opportunities for repeal, replacement, or modification that will result in meaningful burden reduction, while allowing the Agency to achieve its public health mission and fulfill statutory obligations.
The Food and Drug Administration (FDA, the Agency, or we) is making revisions to Chapter I of its regulations. These revisions are necessary to reflect changes to the Agency's organizational structure, including the dissolution of the Regional Food and Drug Director position. The revisions replace references to the Regional Food and Drug Director, who is designated to preside over administrative appeals and at informal hearings on appeal, with references to Office of Regulatory Affairs Program Directors. The rule does not impose any new regulatory requirements on affected parties. This action is editorial in nature and is intended to improve the accuracy of the Agency's regulations.
The Food and Drug Administration (FDA) published a document in the Federal Register on Friday, March 9, 1979 (44 FR 13239). The document established administrative detention procedures for devices intended for human use believed to be adulterated or misbranded. The document was published with a citation in the first column on page 13240 that subsequently was changed by the Nutrition Labeling and Education Act Amendments of 1993. In addition, the document was published with one typographical error in the first column on page 13241. This document corrects these errors.