Documents
Briefs, oral arguments, agency decisions and the Federal Register.
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Medical Devices; Current Good Manufacturing Practice (CGMP) Final Rule; Quality System Regulation
Federal Register · Rule · Oct 7, 1996
Although the November 23, 1993, proposed rule provided a 90 day comment period under the Paperwork Reduction Act of 1980, and this final rule incorporates the comments received, as required by 44 U.S.C … period.
61 FR 52602Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 7, 2023
Background Section 204 of the Food and Drug Administration Modernization Act of 1997 (Pub. L. 105-115) amended section 514 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360d). … Dental/ENT 4-305 Dentistry—Central suction source equipment ISO 10637 Second edition 2018-05. 4-306 Dentistry—Compressed air source equipment ISO 22052 First edition 2020-06.
88 FR 52173Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Jan 16, 1996
Comments During the comment period, FDA received three comments requesting that various devices be added to the list of devices that the agency was proposing to reclassify into class I and/or exempt … According to this comment, the reclassification and exemption for endoscope and accessories should be expanded to include additional endoscope accessories which the comment felt meets the reclassification
61 FR 1117Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Mar 14, 2019
Our CGMP regulations at part 212 (21 CFR part 212) are intended to ensure that PET drug products meet the requirements of the Federal Food, Drug, and Cosmetic Act (FD&C Act) regarding safety, identity, … Schiller, Acting Associate Commissioner for Policy. [FR Doc. 2019-04716 Filed 3-13-19; 8:45 am] BILLING CODE 4164-01-P
84 FR 9347Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Sep 4, 2019
Our CGMP regulations at part 212 (21 CFR part 212) are intended to ensure that PET drug products meet the requirements of the Federal Food, Drug, and Cosmetic Act (FD&C Act) regarding safety, identity, … Three comments were received and are summarized here. One comment questioned the necessity of this proposed collection.
84 FR 46537Health and Human Services DepartmentFood and Drug AdministrationRaidel Figueroa: Final Debarment Order
Federal Register · Notice · Aug 3, 2023
Figueroa advised FDA that Pharmatech was re-engineering its purified water system to prevent contamination of the water used for both production and cleaning purposes. … Figueroa during his period of debarment, other than in connection with an audit under section 306 of the FD&C Act (section 306(c)(1)(B) of the FD&C Act).
88 FR 51328Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Oct 9, 2009
Clarification of the personnel 6-month exemption period; 9. Information on calibrating the air kerma measuring instrument; 10. … FDA periodically updates the information in the PGHS, and this document serves as a further update.
74 FR 52242Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jan 19, 2022
Under section 701(a) of the FD&C Act (21 U.S.C. 371(a)), FDA is authorized to issue regulations for the efficient enforcement of the FD&C Act. … Records are maintained on file at each farm site and examined there periodically by FDA inspectors.
87 FR 2797Health and Human Services DepartmentFood and Drug AdministrationSecuring Updated and Necessary Statutory Evaluations Timely
Federal Register · Rule · Jan 19, 2021
Under the extended sunset date, MHPA requirements do not apply to benefits for services furnished after December 31, 2005.”); see generally Clean Air Council v. Pruitt, 862 F.3d 1, 9 (D.C. … See Clean Air Council v. Pruitt, 862 F.3d 1, 9 (2017) (an agency can amend or revoke a legislative rule through notice-and-comment rulemaking).
86 FR 5694Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jun 27, 2025
Under section 701(a) of the FD&C Act (21 U.S.C. 371(a)), FDA is authorized to issue regulations for the efficient enforcement of the FD&C Act. … Records are compiled and retained at each farm site and examined there periodically by FDA inspectors.
90 FR 27614Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 3, 2018
The statutory basis for FDA conducting this study is derived from the Public Health Service Act (PHS Act) (42 U.S.C. 243, section 311(a)). … Additionally, the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq. ) and the Economy Act (31 U.S.C. 1535) require FDA to provide assistance to other Federal, State, and local government
83 FR 38153Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Oct 28, 1998
Because of the relationship between particular provisions in the warning statement regulation and the HACCP proposal, FDA is announcing its intention to reopen the comment period on the juice HACCP proposal … A Federal Register document announcing the reopening of the juice HACCP proposal comment period will be published at a later date. Transcripts of the workshops will be prepared.
63 FR 57594Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jan 26, 2007
Section 1271.200(e) requires documentation of all equipment maintenance, cleaning, sanitizing, calibration, and other activities. … and section 351 of the PHS Act, that have registered and listed with FDA.
72 FR 3858Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Apr 18, 2016
The Agency has considered all of these comments in drafting this final order. The comments and FDA's responses to the comments are summarized in this section. … An external pacemaker pulse generator (EPPG) is a prescription device that has a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart.
81 FR 22525Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jul 9, 2010
DATES: Fax written comments on the collection of information by August 9, 2010. … ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk
75 FR 39537Health and Human Services DepartmentFood and Drug AdministrationPatrick J. Lais: Debarment Order
Federal Register · Notice · Feb 23, 2010
York manufactured generic over-the-counter drugs during the period January 1999 through July 2001. … Lais during his period of debarment (section 306(c)(1)(B) of the act). Any application by Mr.
75 FR 8081Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Apr 27, 2007
DATES: Fax written comments on the collection of information by May 29, 2007. … and section 351 of the PHS Act that have registered and listed with FDA.
72 FR 21027Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Apr 24, 2019
NW, Suite 300, Washington, DC 20005; the Center for Food Safety, 303 Sacramento St., Second Floor, San Francisco, CA 94111; Clean Water Action, 1444 I St. … Within the 30-day objection period following publication of the 2017 denial, we received one submission raising objections.
84 FR 17113Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Oct 4, 2007
(the act). … This section requires FDA to publish in the Federal Register a notice of intent to exempt a device and provide a comment period. II.
72 FR 56702Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Mar 11, 2010
Section 1271.200(e) requires documentation of equipment maintenance, cleaning, sanitizing, calibration, and other activities. … and section 351 of the PHS Act (42 U.S.C. 262), that have registered and listed with FDA.
75 FR 11545Health and Human Services DepartmentFood and Drug Administration
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