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Medical Devices; Performance Standard for the Infant Apnea Monitor; Withdrawal Notice
Federal Register · Proposed Rule · Sep 22, 2000
Under the classification scheme set forth in section 513 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360c), as amended by the Medical Device Amendments of 1976 (the 1976 amendments … FDA's historical support of these efforts has also been strengthened by the FDA Modernization Act of 1997, which added new section 514(c) to the act, allowing FDA to recognize consensus standards that
65 FR 57303Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Jun 30, 2016
Comment Period Because of the complexity of this proposed rule, we are providing a comment period of 180 days. … period.
81 FR 42912Health and Human Services DepartmentFood and Drug AdministrationSecuring Updated and Necessary Statutory Evaluations Timely; Proposal To Withdraw or Repeal
Federal Register · Proposed Rule · Oct 29, 2021
Length of the Comment Period When HHS promulgated the SUNSET final rule, as discussed above, it provided a 30-day comment period for most comments. … The SUNSET final rule acknowledged the many comments received objecting to the length of the comment period, but concluded that the comment period was sufficient based primarily on the numerous comments
86 FR 59906Health and Human Services DepartmentFood and Drug AdministrationSubstances Prohibited From Use in Animal Food or Feed; Animal Proteins Prohibited in Ruminant Feed
Federal Register · Proposed Rule · Jan 3, 1997
The agency received nearly 600 comments, including many that were submitted long after the comment period ended. The agency has attempted to address the comments in this proposal. … The agency invites comments on the need for a longer retention period related to the BSE incubation period, especially the practicality of using such records for epidemiologic investigation.
62 FR 552Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Nov 24, 2008
for public comment in response to the notice. … the provisions of the act.
73 FR 71006Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Dec 19, 2007
Submit electronic comments by e-mail: standards@cdrh.fda.gov . … Background Section 204 of the Food and Drug Administration Modernization Act of 1997 (FDAMA) (Public Law 105-115) amended section 514 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360d
72 FR 71924Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Mar 16, 2026
Sunlamp products are both “devices” under section 201(h)(1) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 321(h)(1)) and “electronic products” under section 531(2) of the FD&C Act … They are designed to incorporate one or more ultraviolet (UV) lamps intended for irradiation of any part of the living human body, by UV radiation with wavelengths in air between 200 and 400 nanometers
91 FR 12524Health and Human Services DepartmentFood and Drug AdministrationCenter for Devices and Radiological Health: Experiential Learning Program
Federal Register · Notice · Apr 2, 2013
Identify comments with the docket number found in brackets in the heading of this document. … Peter Lurie, Acting Associate Commissioner for Policy and Planning. [FR Doc. 2013-07593 Filed 4-1-13; 8:45 am] BILLING CODE 4160-01-P
78 FR 19711Health and Human Services DepartmentFood and Drug AdministrationDraft Guidance for Industry on Certification of Designated Medical Gases; Availability
Federal Register · Notice · Dec 18, 2012
Title XI, subtitle B, of FDASIA added sections 575 and 576 to the Federal Food, Drug, and Cosmetic Act (the FD&C Act), which created a certification process for designated medical gases. … Specifically, section 575 provides that oxygen, nitrogen, nitrous oxide, carbon dioxide, helium, carbon monoxide, and medical air are designated medical gases.
77 FR 74852Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · May 31, 2001
DATES: Submit written comments on the collection of information by July 2, 2001. … In the Federal Register of February 28, 2001 (66 FR 12798), the agency requested comments on the proposed collection of information. No comments were received.
66 FR 29577Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jun 24, 2010
ADDRESSES: Submit electronic comments on the collection of information to http://www.regulations.gov . … control environmental conditions and inspection result records; (4) requirements for personnel hygiene; (5) procedures for preventing contamination of equipment and products; (6) equipment adjustment, cleaning
75 FR 36092Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Feb 28, 2001
DATES: Submit written comments or electronic comments on the collection of information by April 30, 2001. … procedures to control environmental conditions and inspection result records; requirements for personnel hygiene; procedures for preventing contamination of equipment and products; equipment adjustment, cleaning
66 FR 12798Health and Human Services DepartmentFood and Drug AdministrationRequirements for Additional Traceability Records for Certain Foods
Federal Register · Proposed Rule · Sep 23, 2020
Submit written comments (including recommendations) on the collection of information under the Paperwork Reduction Act of 1995 by November 23, 2020. … We note that this proposed record retention period differs from the retention periods in subpart J (§ 1.360), which applies different record retention requirements depending on the length of time before
85 FR 59984Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · May 9, 2003
FDA believes that a 60-day comment period is appropriate in this instance. … FDA will not consider any comments submitted after the 60-day comment period closes and does not intend to grant any requests for extension of the comment period due to the Bioterrorism Act's December
68 FR 25188Health and Human Services DepartmentFood and Drug AdministrationMedical Devices; Exemptions From Premarket Notification and Reserved Devices; Class I
Federal Register · Notice · Feb 2, 1998
Submit written comments by May 4, 1998. … Comments Interested persons may, on or before May 4, 1998, submit to the Dockets Management Branch (address above) written comments regarding the notice.
63 FR 5387Health and Human Services DepartmentFood and Drug AdministrationAgency Information Collection Activities; Submission for OMB Review; Comment Request
Federal Register · Notice · Jun 15, 1998
DATES: Submit written comments on the collection of information by July 15, 1998. … procedures to control environmental conditions and inspection result records; requirements for personnel hygiene; procedures for preventing contamination of equipment and products; equipment adjustment, cleaning
63 FR 32667Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Uncategorized Document · Mar 31, 1994
DATES: Written comments on the proposed regulation by May 31, 1994; written comments on the agency's economic impact determination by May 31, 1994. … A male patient with a previously normal serum calcium was admitted to the hospital for treatment of hypocalcemia after taking sodium phosphate/sodium biphosphate oral solution to clean the bowel of fecal
Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Oct 18, 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 … control environmental conditions and inspection result records; (4) requirements for personnel hygiene; (5) procedures for preventing contamination of equipment and products; (6) equipment adjustment, cleaning
75 FR 63834Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jul 9, 2007
DATES: Submit written or electronic comments on the collection of information by September 7, 2007. … control environmental conditions and inspection result records; (4) requirements for personnel hygiene; (5) procedures for preventing contamination of equipment and products; (6) equipment adjustment, cleaning
72 FR 37235Health and Human Services DepartmentFood and Drug AdministrationInsanitary Conditions at Compounding Facilities; Guidance for Industry; Availability
Federal Register · Notice · Nov 9, 2020
provides an exemption from section 501(a)(2)(A) of the FD&C Act. … in FDA-approved labeling; adding a footnote to reflect that the FDA does not generally object to rapid movement temporary blocking or disruption of first air in the ISO 5 area when necessary for the safe
85 FR 71348Health and Human Services DepartmentFood and Drug Administration
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