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Federal Register · Notice · May 8, 2007
One of the respondents' comments was received after the 60-day comment period closed and is not addressed. … (Comment 1) One industry respondent wanted assurances from FDA that individual company information was not subject to release under the Freedom of Information Act (FOIA).
72 FR 26132Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · May 9, 2016
ACTION: Notification; extension of comment period. … The Agency has received requests for a 30-day extension of the comment period for the document.
81 FR 28083Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jan 15, 2021
Inspection of Public Comments: All comments received before the close of the comment period are available for viewing by the public, including personally identifiable or confidential business information … Class II Devices Section 510(m)(2) of the FD&C Act, 21 U.S.C. 360(m)(2), provides that, after a 60-calendar-day-notice comment period, “the Secretary may exempt a class II device from the requirement
86 FR 4088Health and Human Services DepartmentFood and Drug AdministrationDiagnostic X-Ray Equipment Performance Standard; Request for Comments and Information
Federal Register · Proposed Rule · Dec 11, 1997
Background FDA, under authority conferred by the Public Health Service Act as amended by the Radiation Control for Health and Safety Act (RCHSA) of 1968 (Pub. … Amendment to require indication of air kerma rate and cumulative air kerma on fluoroscopic systems (Sec. 1020.32(k)).
62 FR 65235Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Jan 8, 2013
Air may be introduced into the extracorporeal circuit and result in a gas embolism. • Adverse tissue reaction. … Defects in the design or construction of the device preventing adequate cleaning and/or sterilization may allow pathogenic organisms to be introduced and may result in infection.
78 FR 1158Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Sep 29, 2016
DSHEA, among other things, amended the Federal Food, Drug, and Cosmetic Act (the FD&C Act) by adding section 402(g) of the FD&C Act (21 U.S.C. 342(g)). … Under section 701(a) of the FD&C Act (21 U.S.C. 371), FDA may issue regulations necessary for the efficient enforcement of the FD&C Act.
81 FR 66967Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Sep 22, 1998
HIMA submitted two comments. One comment requested an extension of the comment period to the economic impact analysis until July 31, 1998. … The fact that many HIMA members submitted responses within the comment period further demonstrates that the period of time was adequate for the submission of comments.
63 FR 50660Amended Economic Impact Analysis of Final Rule Requiring Use ofHealth and Human Services DepartmentMedical Devices; Proposed Classification for Medical Washer and Medical Washer-Disinfector
Federal Register · Proposed Rule · Feb 7, 2002
Background The Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 301 et . … The cleaning phase may automatically dilute and dispense the cleaning agent or may require the user to dilute and add the cleaning agent manually.
67 FR 5750Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Sep 10, 2026
(FD&C Act). … (2) Biocompatibility testing must demonstrate safe residual levels of chemicals on medical devices surfaces and/or gaseous byproducts in air.
91 FR 57507Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · May 3, 2005
ACTION: Notice; extension of comment period. … Efficacy of cleaning procedures and sanitizing agents on environmental surfaces and utensils, 6.
70 FR 22888Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Apr 30, 2026
Comments Submitted by Other Interested Parties: For all comments submitted by other interested parties, submit comments as follows: Electronic Submissions Submit electronic comments in the following … Medpace was responsible for tracking post-adjudication data changes and providing the AC Chair or designee with periodic listings of data changes (Ref. 8, Addendum 2, § 4.3.3).
91 FR 23278Health and Human Services DepartmentFood and Drug AdministrationEgg Safety Action Plan; Public Meetings
Federal Register · Notice · Mar 21, 2000
The information shared at the public meetings and during the comment period for the public meetings will be carefully considered as the new regulations are crafted. … Is there a way to clean plastic containers to prevent cross contamination so they can be re-used? 17.
65 FR 15119Agriculture DepartmentFood Safety and Inspection ServiceFederal Register · Rule · Nov 6, 1998
One comment expressed concern that FDA stated that the operational period will start at the end of the transition period, and that FDA did not state that the transition period will be for a period of 3 … One comment commented on the 90-day period provided for obtaining an inspection and requested provision for extension of this period for good cause.
63 FR 60122Mutual Recognition of Pharmaceutical Good Manufacturing PracticeInspection Reports, Medical Device Quality System Audit Reports, andMedical Devices; Exemptions From Premarket Notification: Class II Devices; Request for Comments
Federal Register · Notice · Mar 14, 2017
FDA will review any comments submitted within the 60-day comment period and will consider whether the list of class II devices should be modified prior to publication of its final determination in the … Additionally, FDA must provide at least a 60-day comment period for any such notice required to be published under section 510(m)(1)(A) of the FD&C Act.
82 FR 13609Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Apr 1, 2005
Section 800.12 requires that packages of contact lens cleaning solutions include a tamper-resistant feature to prevent malicious adulteration. … Section 801.410(f) requires that results of impact tests and description of the test method and apparatus be kept for a period of 3 years.
70 FR 16824Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 9, 2011
Further, § 800.12 requires that packaged contact lens cleaning solutions contain a tamper-resistant feature, to prevent malicious adulteration. … Section 801.410(f) requires that the results of impact tests and description of the test method and apparatus be retained for a period of 3 years.
76 FR 48866Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Oct 13, 2015
Section 301 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 331) prohibits the introduction, or delivery for introduction, into interstate commerce of cosmetics that are adulterated … The estimated burdens for developing recordkeeping includes record maintenance, periodically reviewing records to determine if they may be discarded, and any associated documentation for that activity.
80 FR 61430Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Dec 14, 2004
Section 800.12 requires that packages of contact lens cleaning solutions include a tamper-resistant feature to prevent malicious adulteration. … Section 801.410(f) requires that results of impact tests and description of the test method and apparatus be kept for a period of 3 years.
69 FR 74529Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 4, 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 47765Health and Human Services DepartmentFood and Drug AdministrationMedical Devices; Classification for Medical Washer and Medical Washer-Disinfector
Federal Register · Rule · Nov 15, 2002
All three comments agreed with the proposed rule. In addition, one comment suggested that FDA require manufacturers to include testing to monitor cleaning efficacy. III. … One comment also suggested that FDA require manufacturers to include testing to monitor cleaning efficacy. Currently, there is no standard for validating cleaning efficacy.
67 FR 69119Health and Human Services DepartmentFood and Drug Administration
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