The "Déjà Vu Effect:" Evaluation of United States medical device legislation, regulation, and the Food and Drug Administration's contentious 510(k) program

Food and Drug Law Journal

Volumn 67, Issue 3, 2012, Pages 337-361

  Bauman, Jordan ^a  

^a CardioMEMS Inc   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ACT; BILLING AND CLAIMS; COSMETIC INDUSTRY; COST EFFECTIVENESS ANALYSIS; DECISION MAKING; FOOD AND DRUG ADMINISTRATION; GOVERNMENT REGULATION; HUMAN; LAW; MARKETING; MEDICAL DECISION MAKING; MEDICAL DEVICE; MEDICOLEGAL ASPECT; QUALITY CONTROL; REVIEW; UNITED STATES;

EQUIPMENT SAFETY; GOVERNMENT REGULATION; HUMANS; MEDICAL DEVICE LEGISLATION; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84868290256     PISSN: 1064590X     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (138)

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64. GAO Report - 1988. Medical devices: FDA's 510(k) operations could be improved. Report to the chairman, Subcommittee on Health and the Environment, Committee on Energy and Commerce, House of Representatives (PEMD-88-14). Washington, DC: General Accounting Office. "substantial equivalence does not imply safe or effective"
65. Memorandum Re: Internal Control Weaknesses in the Food and Drug Administration's Medical Device 510(k) Review Process, from the HHS inspector general to the HHS assistant secretary for health (July 5, 1990). "substantial equivalence does not imply safe or effective"
66. Safe Medical Devices Act (SMDA), Pub. L. No. 101-629, 104 Stat. 4511 (1990)
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68. FFDCA § 513(i)(1), 21 USC § 360c(i)(1) (2006) (as modified by SMDA, § 5(a)(2), 104 Stat. at 4517-18). "expanded tools available to FDA to satisfy special controls provision for class II devices"
69. FFDCA § 513(a)(1)(B), 21 USC § 360c(a)(1)(B) (2006). "Class II device"
70. FFDCA § 514(a)(1), 21 USC § 360d(a)(1) (2006). "FDA discretion to implement special controls"
71. FFDCA § 514(b), 21 USC 360d(b) (2006) (as modified by SMDA § 6(a), 104 Stat. at 4519). "updated rulemaking procedure for performance standard promulgation"
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73. H.R. Rep. No. 101-808 (1990)
74. FFDCA § 513(i)(1), 21 USC § 360c(i)(1) (2006) (added by SMDA § 12, 104 Stat. at 4523). "Defining substantial equivalence standard"
75. H.R. Rep. No. 101-808, (1990) "final agency action"
76. H.R. Rep. No. 101-808, (1990). "evolution of safety and efficacy with substantial equivalence"
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78. H.R. Rep. No. 100-782 at 4 and 23. (1988). "predicate defined as comparable devices in interstate commerce"
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112. Working Group Report. 2010.
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