Source: https://www.law.cornell.edu/cfr/text/21/part-800
Timestamp: 2018-04-26 04:13:25
Document Index: 68911766

Matched Legal Cases: ['art 800', 'art 800', 'art 800', '§ 800', '§ 800', 'art 800', 'arts 10', 'arts 1', 'art 800']

21 CFR Part 800 - GENERAL | US Law | LII / Legal Information Institute
CFR › Title 21 › Chapter I › Subchapter H › Part 800
21 CFR Part 800 - GENERAL
Subpart B - Requirements for Specific Medical Devices (§§ 800.10 - 800.20)
Subpart C - Administrative Practices and Procedures (§ 800.55)
21 U.S.C. 321, 334, 351, 352, 355, 360e, 360i, 360k, 361, 362, 371.
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.
2018-01-17; vol. 83 # 11 - Wednesday, January 17, 2018
83 FR 2388 - Internal Agency Review of Decisions; Requests for Supervisory Review of Certain Decisions Made by the Center for Devices and Radiological Health
FR Doc. 2018-00646
RIN 0910-AH37
Docket No. FDA-2016-N-2378
Submit either electronic or written comments by April 17, 2018. See section V of this document for the proposed effective date of a final rule that may issue based on this proposal.
21 CFR Parts 10 and 800
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&apos;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.
82 FR 14143 - Presiding Officer for an Appeal and Informal Hearing; Technical Amendments
FR Doc. 2017-05350
Docket No. FDA-2017-N-0011
This rule is effective March 17, 2017.
21 CFR Parts 1, 101, 112, 115, 117, 118, 507, and 800
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&apos;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&apos;s regulations.
2014-02-19; vol. 79 # 33 - Wednesday, February 19, 2014
79 FR 9412 - Administrative Detention; Corrections
FR Doc. 2014-03582
Docket No. FDA-1977-N-0222
This correction is effective February 19, 2014.
21 CFR Part 800
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.