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Federal Register · Notice · Mar 3, 2021
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). … Such standards are those that FDA has recognized by notice published in the Federal Register or that FDA has decided to recognize but for which recognition is pending (because a periodic notice has
86 FR 12476Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Feb 4, 2022
Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by March 7, 2022. ADDRESSES: You may submit comments as follows. … (A) A cleaning program schedule must be maintained, documented, and followed.
87 FR 6708Health and Human Services DepartmentFood and Drug AdministrationDental Devices; Classification for Intraoral Devices for Snoring and/or Obstructive Sleep Apnea
Federal Register · Proposed Rule · Apr 5, 2002
TMJ dysfunction syndrome may result from use of the devices if the TMJ is strained or if the muscular attachments are stretched for prolonged periods. … Act of 1995.
67 FR 16338Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Mar 13, 2007
Draft Final Guidance for Industry: Guide to Minimize Food Safety Hazards for Fresh-Cut Fruits and Vegetables Description : The Federal Food, Drug, and Cosmetic Act (the act) prohibits the distribution … Sanitation activities include procedures for cleaning equipment, food-contact surfaces and plant facilities; chemical use and storage; cleaning equipment maintenance, use, and storage; pest control; and
72 FR 11364Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Apr 3, 2019
(FD&C Act) (21 U.S.C. 341, 343, and 371). … Mandates Reform Act of 1995 (Pub.
84 FR 12975Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · May 6, 2024
Some comments indicate that the Clean Water Act (CWA) requires State and/or Federal governments to hold polluters accountable, suggesting that it is therefore unjust to place that responsibility on farms … EPA, “Summary of the Clean Water Act,” 2023. Available at: https://www.epa.gov/laws-regulations/summary-clean-water-act . *38.
89 FR 37448Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Sep 25, 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 46213Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Dec 23, 2016
Background Section 204 of the Food and Drug Administration Modernization Act of 1997 (FDAMA) (Pub. … L. 105-115) amended section 514 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360d).
81 FR 94388Health and Human Services DepartmentFood and Drug AdministrationApplication of Good Guidance Practices to Revisions to the Shellfish Sanitation Model Ordinance
Federal Register · Notice · Jun 26, 1997
Program for Molluscan Shellfish FDA is responsible for enforcing, among other laws, the Federal Food, Drug, and Cosmetic Act and certain portions of the Public Health Service Act. … Since the Manual of Operations was written, FDA has published the manual and periodic revisions to it and has issued interpretations of its provisions.
62 FR 34480Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; EXEM FOAM
Federal Register · Notice · Jun 20, 2025
Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by December 17, 2025. … Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
90 FR 26311Health and Human Services DepartmentFood and Drug AdministrationMedical Devices; Laboratory Developed Tests
Federal Register · Rule · May 6, 2024
Id. at 2609 (cleaned up). … One comment noted that the VALID Act had proposed a transition period of up to 10 years.
89 FR 37286Health and Human Services DepartmentFood and Drug AdministrationIrradiation in the Production, Processing and Handling of Food
Federal Register · Rule · Dec 3, 1997
The other FWI submission also requested an extension of the ``comment'' [sic] period. III. … FDA notes that FWI misinterprets the statutory 30-day objection period, which is specified in section 409(f) of the act, as an opportunity for comment.
62 FR 64102Mines BureauHealth and Human Services DepartmentEffective Date of Requirement for Premarket Approval for Blood Lancets
Federal Register · Rule · Nov 22, 2021
Section 515(b)(3) of the FD&C Act provides that FDA shall, after the close of the comment period on the proposed order, consideration of any comments received, and a meeting of a device classification … The comments and FDA responses to the comments are summarized in this section.
86 FR 66177Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Nov 6, 1998
DATES: Written comments by February 4, 1999. … In the Federal Register of May 22, 1997 (62 FR 28055), FDA extended the period to comment on the draft guidance until August 20, 1997.
63 FR 59917Health and Human Services DepartmentFood and Drug AdministrationOphthalmic Devices; Reclassification of Ultrasound Cyclodestructive Device
Federal Register · Proposed Rule · Sep 25, 2018
ADDRESSES: You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before November 26, 2018. … If the device contains reusable eye-contact components, the validation tests must demonstrate adequate cleaning/reprocessing of these components.
83 FR 48403Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jun 7, 2018
Background Section 204 of the Food and Drug Administration Modernization Act of 1997 (FDAMA) (Pub. … L. 105-115) amended section 514 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360d).
83 FR 26465Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Sep 16, 2024
(FD&C Act). … use with the delivery system; (B) Description of the safety-related components included in the system; (C) Identification of operational parameters; (D) Alarms and troubleshooting information; (E) Cleaning
89 FR 75493Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Jun 2, 2014
The proposed order also called for comments from any interested stakeholders. The comment period on the proposed order closed on August 7, 2013. … (B) Manufacturers shall provide validated instructions on cleaning and disinfection of sunlamp products between uses in the user instructions.
79 FR 31205Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Nov 16, 2010
Clarification of the personnel 6-month exemption period; 8. Information on calibrating the air kerma measuring instrument; 9. … The comment period closed on January 7, 2010. During the public comment period, 4 respondents submitted a total of 14 comments.
75 FR 70011Health and Human Services DepartmentFood and Drug AdministrationMedical Devices; Exemptions From Premarket Notification; Class II Devices
Federal Register · Notice · Jan 21, 1998
The agency will review any comments submitted within the 90-day comment period and will consider whether the list of class II devices that are exempt from the premarket notification requirements should … This section requires FDA to publish in the Federal Register a notice of intent to exempt a device, or of the petition, and to provide a 30-day comment period.
63 FR 3142Health and Human Services DepartmentFood and Drug Administration
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