Documents
Briefs, oral arguments, agency decisions and the Federal Register.
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Microbiology Devices; Classification of In Vitro Diagnostic Device for Bacillus Species Detection
Federal Register · Proposed Rule · May 18, 2011
Lohr 518 U.S. 470 (1996); Riegel v. Medtronic, 552 U.S. 312 (2008). … et al., “Phage isolated from lysogenic Bacillus anthracis,” vol. 85, Journal of Bacteriology, p. 423, 1963.
76 FR 28689Health and Human Services DepartmentFood and Drug AdministrationRadiology Devices; Reclassification of Medical Image Analyzers
Federal Register · Proposed Rule · Jun 4, 2018
FDA, 766 F.2d 592 (DC Cir.1985), cert. denied, 474 U.S. 1062 (1986)). FDA relies upon “valid scientific evidence” in the classification process to determine the level of regulation for devices. … Ferré, et al., “Computed-Aided Diagnosis (CAD) in the Detection of Breast Cancer,” European Journal of Radiology, 82(3): 417-423 (2013). 6. Fenton, J.J., G. Xing, J.G.
83 FR 25598Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Oct 11, 2012
Murray and colleagues (Ref. 7) also conducted a large-scale survey of U.S. physicians regarding their perceptions of DTC, but they also did not include nurse practitioners or physician assistants in their … Food and Drug Law Journal, 57, 423-443, 2002. 3. Curry, T.J., J. Jarosch, and S. Pacholok, “Are Direct to Consumer Advertisements of Prescription Drugs Educational? Comparing 1992 to 2002.”
77 FR 61761Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · May 9, 2003
Division of Compliance Policy, Office of Enforcement, Office of Regulatory Affairs, U.S. Food and Drug Administration, U.S. … Bureau of Economic Analysis, U.S. Department of Commerce, U.S. International Transactions Accounts Data, table 2, U.S.
68 FR 25242Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Apr 28, 2014
See Central Hudson, 447 U.S. at 563; see also In re R.M.J., 455 U.S. at 203. … (per curiam), cert denied, 423 U.S. 827 (1975); Continental Wax Corp. v. FTC, 330 F.2d 475, 480 (2d Cir. 1964); United States v.
79 FR 23262Health and Human Services DepartmentFood and Drug AdministrationAmendments to Registration of Food Facilities
Federal Register · Proposed Rule · Apr 9, 2015
FSMA also created section 423 of the FD&C Act (21 U.S.C. 350 l ), which provides a “responsible party” an opportunity to voluntarily cease distribution and recall a food under specified circumstances … functions, with the passage of FSMA and FDAAA, food facility registration now also serves to determine the applicability of provisions in other sections of the FD&C Act, including sections 417, 418, 421, 423
80 FR 19160Health and Human Services DepartmentFood and Drug AdministrationGeneral and Plastic Surgery Devices; Reclassification of Certain Surgical Staplers
Federal Register · Proposed Rule · Apr 24, 2019
Cir.1985), cert. denied, 474 U.S. 1062 (1986)). FDA relies upon “valid scientific evidence” in the classification process to determine the level of regulation for devices. … associated with use error, a prospective, single-arm study evaluating use of a surgical stapler in gastrointestinal stapling applications found that 3.5 percent of stapler deployments in the study (15 of 423
84 FR 17116Health and Human Services DepartmentFood and Drug AdministrationMedical Devices; Establishment of a Performance Standard for Electrode Lead Wires and Patient Cables
Federal Register · Rule · May 9, 1997
FDA, 637 F.2d 877 (2d Cir.), cert. denied, 423 U.S. 827 (1975).) … \18\ U.S. Industrial Outlook, U.S.
62 FR 25477Health and Human Services DepartmentFood and Drug AdministrationRequired Warnings for Cigarette Packages and Advertisements
Federal Register · Proposed Rule · Nov 12, 2010
at p. 423). … at pp. 423, 508-509).
75 FR 69524Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Apr 25, 2016
FDA also received a comment from the U.S. … Lohr, 518 U.S. 470 (1996); and Riegel v. Medtronic, 128 S. Ct. 999 (2008)).
81 FR 24386Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Sep 17, 2015
U.S., 531 U.S. 159 (2001)). … (See section 423(a) of the FD&C Act (21 U.S.C. 350l).)
80 FR 55908Health and Human Services DepartmentFood and Drug AdministrationSecuring Updated and Necessary Statutory Evaluations Timely
Federal Register · Rule · Jan 19, 2021
The U.S. … Assn. of U.S., Inc. v. State Farm Mut. Auto. Ins. Co., 463 U.S. 29, 43 (1983)).
86 FR 5694Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Aug 2, 2012
year. 12 At a labor rate of $41 per hour, including benefits, registration and listing costs $103 per device or $520 per contract manufacturing establishment ($103 per listing × 5.05 listings) and $482 … According to the U.S.
77 FR 45927Health and Human Services DepartmentFood and Drug AdministrationAmendments to Registration of Food Facilities
Federal Register · Rule · Jul 14, 2016
FSMA also created section 423 of the FD&C Act (21 U.S.C. 3501), which provides a “responsible party” an opportunity to voluntarily cease distribution and recall a food under specified circumstances and … functions, with the passage of FSMA and FDAAA, food facility registration now also serves to determine the applicability of provisions in other sections of the FD&C Act, including sections 417, 418, 421, 423
81 FR 45912Health and Human Services DepartmentFood and Drug AdministrationLaboratory Accreditation for Analyses of Foods
Federal Register · Proposed Rule · Nov 4, 2019
U.S. … In the domestic context, the U.S.
84 FR 59452Health and Human Services DepartmentFood and Drug AdministrationAnnual Comprehensive List of Guidance Documents at the Food and Drug Administration
Federal Register · Notice · Mar 28, 2006
Updated Interim U.S. Case Definition of Severe Acute Respiratory Syndrome (SARS). http://www.cdc.gov/ncidod/sars/casedefinition.htm. … ANSI/ISO/ASQC Q9001 and ISO/DI 13485:1996 OCER/DSMICA 133 (167) DRAFT Guidance for Staff, Industry and U.S.
71 FR 15422Health and Human Services DepartmentFood and Drug AdministrationUse of Ozone-Depleting Substances; Removal of Essential-Use Designations
Federal Register · Proposed Rule · Jun 11, 2007
Since 1978, the U.S. … Current U.S.
72 FR 32030Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Jan 18, 2001
denied , 423 U.S. 827 (1975). … U.S.
66 FR 4688Health and Human Services DepartmentFood and Drug AdministrationSurgeon's and Patient Examination Gloves; Reclassification
Federal Register · Proposed Rule · Jul 30, 1999
Weinberger, 512 F.2d 688 (2d Cir.), cert. denied, 423 U.S. 825 (1975).) … U.S. Department of Commerce, U.S. Industrial Outlook, 1994. 42. Katz, M. L., and H. Rosen, Microeconomics, 2d Ed., Irwin Press, 1998. 43. U.S.
64 FR 41710Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Jan 6, 2000
Weinberger, 512 F.2d 688, 702 (2d Cir. 1975), cert. denied, 423 U.S. 827 (1975).) … Shrewsbury Township, 808 F.2d 1023, 1031 (3d Cir.), cert. denied, 482 U.S. 906 (1987) (citing Hadacheck v. Sebastian, 239 U.S. 394 (1915) (reduction in value from $800,000 to $60,000); Euclid v.
65 FR 1000Regulations on Statements Made for Dietary Supplements Concerning theRule
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