Source: https://www.prolekare.cz/casopisy/plos-medicine/2010-7/left-to-their-own-devices-breakdowns-in-united-states-medical-device-premarket-review-44537
Timestamp: 2019-09-19 01:59:46
Document Index: 255731958

Matched Legal Cases: ['§ 321', '§ 360', '§ 355', '§ 360', '§ 314', '§ 860', '§ 360', 'art 1', '§ 360', '§ 360', '§ 807', '§360', '§360', '§360']

Left to Their Own Devices: Breakdowns in United States Medical Device Premarket Review | proLékaře.cz
proLékaře.cz / Odborné časopisy / PLOS Medicine / 2010 - 7 / Left to Their Own Devices: Breakdowns in United States Medical Device Premarket Review
Published in the journal: . PLoS Med 7(7): e32767. doi:10.1371/journal.pmed.1000280
Tab. 1. Summary of statutory and regulatory issues, case exemplars, and necessary corrective actions.
Although these weaknesses are susceptible to shifts in agency discretionary practices, such changes are not sufficient; for consistent and meaningful improvement, these laws and regulations must be revisited and strengthened.
Fig. 1. Schematic representation of medical device premarket review mechanisms.
Fig. 2. Class III 510(k) device types not fully reviewed by the FDA, 1976–2009.
1. 2006 Definition of a medical device. Washington, DC Government Printing Office. Federal food, drug, and cosmetic act Publication No. 21 USC § 321(h) (2006 ed.)
2. RamseySD
LuceBR
1998 The limited state of technology assessment for medical devices: facing the issues. Am J Manag Care 4 Spec No SP188 199
3. RolandG
DonahoeG
2009 Estimates of medical device spending in the United States, 1989-2006. Available: http://www.advamed.org/NR/rdonlyres/6ADAAA5B-BA37-469E-817B-3D61DEC4E7C8/0/King2009FINALREPORT52909.pdf. Accessed January 17, 2010
4. Centers for Disease Control and Prevention 1983 Elevated risk of pelvic inflammatory disease among women using the Dalkon Shield. Morb Mortal Wkly Rep 32 221 222
5. U.S. House of Representatives, Committee on Energy and Commerce, Subcommittee on Oversight and Investigations 1990 The Bjork-Shiley heart valve: earn as you learn; Shiley Inc.'s breach of the honor system and FDA's failure in medical device regulation: a staff report. Washington, DC Government Printing Office. Comm. Print 1990
6. SchultzD
2007 Statement on Medtronic's Voluntary Market Suspension of Their Sprint Fidelis Defibrillator Leads. Rockville, MD: Food and Drug Administration. Available: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2007/ucm109007.htm. Accessed January 16, 2010
7. MaiselWH
2004 Medical device regulation: an introduction for the practicing physician. Ann Intern Med 140 296 302
8. Center for Devices and Radiological Health 2009 Device classification. Rockville, MD: Food and Drug Administration. Available: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/ClassifyYourDevice/default.htm. Accessed January 17, 2010
9. Center for Devices and Radiological Health 1986 Guidance on the CDRH premarket notification review program. Rockville, MD: Food and Drug Administration. 510(k) Memorandum #K86-3. Available: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm081383.htm. Accessed January 17, 2010
10. 2006 Substantial equivalence defined. Washington, DC Government Printing Office Federal food, drug, and cosmetic act. Publication No. 21 USC § 360c(i)(1) (2006 ed.)
11. Government Accountability Office 2009 Medical devices: FDA should take steps to ensure that high-risk device types are approved through the most stringent premarket review process. Washington, DC: Government Printing Office. Publication No. GAO-09-190. Available: http://www.gao.gov/new.items/d09190.pdf. Accessed January 17, 2010
12. 2006 Grounds for refusing application; approval of application; substantial evidence defined. Washington, DC Government Printing Office Federal food, drug, and cosmetic act. Publication No. 21 USC § 355(d) (2006 ed.)
13. 2006 Classes of devices. Washington, DC Government Printing Office. Federal food, drug, and cosmetic act. Publication No. 21 USC § 360c(a) (2006 ed.)
14. Center for Drug Evaluation and Research 1998 Providing clinical evidence of effectiveness for human drug and biological products. Rockville, MD: Food and Drug Administration. Available: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm072008.pdf. Accessed January 17, 2010
15. 1995 Statement regarding the demonstrations of effectiveness of human drug products and devices. Federal register. Washington, DC: Government Printing Office. Publication No. 60 FR 39180-39181 (August 1, 1995)
16. Government Accountability Office 2006 Medicare durable medical equipment: class III devices do not warrant a distinct annual payment update. Washington, DC: Government Printing Office. Publication No. GAO-06-62. Available: http://www.gao.gov/new.items/d0662.pdf. Accessed January 17, 2010
17. 2009 Applications for FDA approval to market a new drug; uncontrolled studies or partially controlled studies. Code of federal regulations. Washington DC: Government Printing Office. Publication No. 21 CFR § 314.126(e) (April 2009 ed.)
18. 2009 Medical device classification procedures; determination of safety and effectiveness; absence of well-controlled investigations. Code of federal regulations. Washington DC: Government Printing Office. Publication No. 21 CFR § 860.7(e)(2) (April 2009 ed.)
19. RushAJ
MarangellLB
SackeimHA
2005 Vagus nerve stimulation for treatment-resistant depression: a randomized, controlled acute phase trial. Biol Psychiatry 58 347 354
20. United States Senate, Committee on Finance 2006 Review of the FDA's approval process for the vagus nerve stimulation therapy system for treatment-resistant depression. Washington, DC: Government Printing Office. Publication No. S. Prt. 109-45. Available: http://finance.senate.gov/press/Gpress/02_2006%20report.pdf. Accessed January 17, 2010
21. Coverage Analysis Group 2007 Decision memo for vagus nerve stimulation for treatment of resistant depression (TRD). Baltimore, MD: Centers for Medicare and Medicaid Services. Available: http://www.cms.hhs.gov/mcd/viewdecisionmemo.asp?from2=viewdecisionmemo.asp&id=%20195&. Accessed January 17, 2010
22. LurieP
WolfeSM
2006 Letter requesting that Medicare deny reimbursement for Cyberonics' vagus nerve stimulation device for treatment-resistant depression. Washington, DC: Health Research Group, Public Citizen. Available: http://www.citizen.org/publications/release.cfm?ID=7456. Accessed January 17, 2010
23. Food and Drug Administration 2008 Office of device evaluation: annual report fiscal year 2006 and fiscal year 2007: key performance indices. Rockville, MD: Food and Drug Administration. Available: http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHReports/ucm126933.htm. Accessed January 17, 2010
24. 2006 Withdrawal and temporary suspension of approval of application. Washington, DC Government Printing Office. Federal food, drug, and cosmetic act. Publication No. 21 USC § 360e(e) (2006 ed.)
25. CDRH Office of Device Evaluation 1998 Guidance for industry: general/specific intended use. Rockville, MD: Food and Drug Administration. Available: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm073944.htm. Accessed January 17, 2010
26. Medicare and Medicaid programs; quarterly listing of program issuances and coverage decisions; third quarter 1995 1996 Federal register. Washington, DC Government Printing Office. Publication No. 61 FR 15491-15504 (April 8, 1996)
27. Food and Drug Administration 2009 Review of the Regen Menaflex: departures from processes, procedures, and Practices leave the basis for a review decision in question, preliminary report. Rockville, MD: Food and Drug Administration. Available: http://www.fda.gov/downloads/NewsEvents/PublicHealthFocus/UCM183642.pdf. Accessed January 17, 2010
28. ReGen Biologics 2005 ReGen Biologics to present at the pacific growth equities life science conference in San Francisco on June 6, 2005 [press release]. Available: http://www.regenbio.com/usa/en/pressroom/594/. Accessed January 17, 2010
29. Center for Devices and Radiological Health 2008 FDA summary for the Orthopedic and Rehabilitative Devices Panel for the ReGen Collagen Scaffold. Rockville, MD: Food and Drug Administration. Available: http://www.fda.gov/ohrms/dockets/ac/08/briefing/2008-4400b1-01FDA%20Summary%20and%20Questions%20.pdf. Accessed January 17, 2010
30. HinesJ
2008 Testimony before FDA on Collagen Scaffold medical device. Washington, DC: Health Research Group, Public Citizen. Available: http://www.citizen.org/publications/release.cfm?ID=7620. Accessed January 17, 2010
31. [No authors listed] 2008 Premarket notification; ReGen Menaflex Collagen Scaffold (MCS). Hackensack, NJ: ReGen Biologics. Available: http://www.fda.gov/ohrms/dockets/ac/08/briefing/2008-4400b1-01%20510(k)%20Intro%20K082079.pdf. Accessed January 17, 2010
32. Center for Devices and Radiological Health 2008 Transcript of the Orthopedic and Rehabilitative Devices Panel of the Medical Devices Advisory Committee: part 1. Rockville, MD: Food and Drug Administration. Available: http://www.fda.gov/ohrms/dockets/ac/08/transcripts/2008-4400t01.pdf. Accessed January 17, 2010
33. Coverage Analysis Group 2010 Proposed Decision Memo for Collagen Meniscus Implant. Baltimore, MD: Centers for Medicare and Medicaid Services. Available: http://www.cms.hhs.gov/mcd/viewdraftdecisionmemo.asp?id=235. Accessed March 25, 2010
34. 2006 Different technological characteristics. Washington, DC Government Printing Office Federal food, drug, and cosmetic act. Publication No. 21 USC § 360c(i)(1)(A)(ii) (2006 ed)
35. Center for Devices and Radiological Health 2007 FDA Summary for meeting of the Neurological Devices Panel for Neurostar TMS system. Rockville, MD: Food and Drug Administration. Available: http://www.fda.gov/ohrms/dockets/ac/07/briefing/2007-4273b1_01-FDAExecutiveSummary.pdf. Accessed January 17, 2010
36. O'ReardonJP
SolvasonHB
JanicakPG
IsenbergKE
2007 Efficacy and safety of transcranial magnetic stimulation in the acute treatment of major depression: a multisite randomized controlled trial. Biol Psychiatry 62 1208 1216
37. LurieP
2007 Testimony at meeting on repetitive transcranial magnetic stimulation, Duraseal and vagus nerve stimulation. Washington, DC: Health Research Group, Public Citizen. Available: http://www.citizen.org/publications/release.cfm?ID=7499. Accessed January 17, 2010
38. Center for Devices and Radiological Health 2007 Transcript of the Neurological Devices Panel of the Medical Devices Advisory Committee. Rockville, MD: Food and Drug Administration. Available: http://www.fda.gov/ohrms/dockets/ac/07/transcripts/2007-4273t1.rtf. Accessed January 17, 2010
39. 2006 Evaluation of automatic class III designation. Washington, DC Government Printing Office. Federal food, drug, and cosmetic act. Publication No. 21 USC § 360c(f)(2) (2006 ed.)
40. LisanbySH
HusainMM
RosenquistPB
MaixnerD
2009 Daily left prefrontal repetitive transcranial magnetic stimulation in the acute treatment of major depression: clinical predictors of outcome in a multisite, randomized controlled clinical trial. Neuropsychopharmacology 34 522 534
41. HinesJZ
2009 Reply to Lisanby et al. Post hoc analysis does not establish effectiveness of rTMS for depression. Neuropsychopharmacology 34 2053 2054
42. Center for Devices and Radiological Health 2009 510(k) device database [searched ‘CLEARED FOR MARKETING AUTOMATIC CLASS III DESIGNAT (AN)’ under ‘Decision’ field]. Rockville, MD: Food and Drug Administration. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm. Accessed January 17, 2010
43. Center for Devices and Radiological Health 2008 510(k) substantial equivalence determination decision summary for Pathwork Tissue of Origin Test. Rockville, MD: Food and Drug Administration. Available: http://www.accessdata.fda.gov/cdrh_docs/reviews/K080896.pdf. Accessed January 17, 2010
44. Center for Devices and Radiological Health 2005 510(k) substantial equivalence determination decision summary for BioPlex 2200 Medical Decision Support Software on the BioPlex 2200 Multi-Analyte Detection System. Rockville, MD: Food and Drug Administration. Available: http://www.accessdata.fda.gov/cdrh_docs/reviews/K043341.pdf. Accessed January 17, 2010
45. Government Accountability Office [formerly known as the United States General Accounting Office] 1988 Medical devices: FDA's 510(k) operations could be improved. Washington, DC: Government Printing Office. Publication No. GAO/PEMD-88-14. Available: http://archive.gao.gov/d16t6/136821.pdf. Accessed January 17, 2010
46. 1988 General and plastic surgery devices; general provisions and classifications of 51 devices. Federal register. Washington, DC: Government Printing Office. Publication No. 53 FR 23856-23877 (June 24, 1988)
47. 2009 Establishment registration and device listing for manufacturers and initial importers of devices; exemption from premarket notification. Code of federal regulations. Washington DC: Government Printing Office. Publication No. 21 CFR § 807.85(b)(1) (April 2009 ed.)
48. CDRH Office of Device Evaluation 1994 Memorandum: preamendments Class III strategy. Rockville, MD: Food and Drug Administration. Available: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm081251.htm. Accessed January 17, 2010
49. 2006 Revision of class III preamendments devices classifications. Washington, DC Government Printing Office. Federal food, drug, and cosmetic act. Publication No. 21 USC §360e(i) (2006 ed.)
50. 2009 Order for certain class III devices; submission of safety and effectiveness information. Federal register. Washington, DC: Government Printing Office. Publication No. 74 FR 16214-16217 (April 9, 2009)
51. Center for Devices and Radiological Health 2009 510(k) device database [searched ‘DSP’ under ‘Product Code’ field]. Rockville, MD: Food and Drug Administration. Available: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm. Accessed January 17, 2010
52. CohenM
ChristensonJT
FreedmanRJJr
2003 Intra-aortic balloon counterpulsation in US and non-US centres: results of the Benchmark Registry. Eur Heart J 24 1763 1770
53. Center for Devices and Radiological Health 2009 Medical device classification database [searched ‘unclassified’ under ‘Device Class’ field; searched ‘510(k)’ under ‘Submission Type’ field]. Rockville, MD: Food and Drug Administration. Available: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm. Accessed January 17, 2010
54. CDRH Office of the Center Director 2001 Resolving scientific disputes concerning the regulation of medical devices: a guide to use of the medical devices dispute resolution panel. Rockville, MD: Food and Drug Administration. Available: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm110237.htm. Accessed January 17, 2010
55. Center for Devices and Radiological Health 2001 Summary of safety and effectiveness data for GYNECARE INTERGEL adhesion prevention solution. Rockville, MD: Food and Drug Administration. Available: http://www.accessdata.fda.gov/cdrh_docs/pdf/P990015b.pdf. Accessed January 17, 2010
56. Center for Devices and Radiological Health 2003 Urgent global market withdrawal: GYNECARE INTERGEL Adhesion Prevention solution voluntarily withdrawn from the market by GYNECARE worldwide. Rockville, MD: Food and Drug Administration. Available: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm170010.htm. Accessed January 16, 2010
57. 2006 Least burdensome approach for 510(k) devices with different technological characteristics. Washington, DC Government Printing Office. Federal food, drug, and cosmetic act. Publication No. 21 USC §360c(i)(1)(D) (2006 ed.)
58. 2006 Least burdensome approach for evaluating effectiveness of PMA devices. Washington, DC Government Printing Office. Federal food, drug, and cosmetic act. Publication No. 21 USC §360c(a)(3)(D)(ii) (2006 ed.)
59. DichiaraJ
2007 Letter to Mark N. Melkerson responding to request for additional information for ReGen's Collagen Scaffold. Hackensack, NJ: ReGen Biologics. Available: http://www.fda.gov/OHRMS/DOCKETS/ac/08/briefing/2008-4400b1-28-%20C.pdf. Accessed January 17, 2010
60. Food and Drug Administration 2009 Agenda for Quarterly Meeting on MDUFMA/MDUFA Performance. Washington, DC: Rockville, MD: Food and Drug Administration. Available: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/MedicalDeviceUserFeeandModernizationActMDUFMA/ucm148074.htm. Accessed January 17, 2010
61. DhruvaSS
RedbergRF
2009 Strength of study evidence examined by the FDA in premarket approval of cardiovascular devices. JAMA 302 2679 2685
62. KramerDB
ZuckermanBD
ZimmermanBA
MaiselWH
2010 Premarket clinical evaluation of novel cardiovascular devices: quality analysis of premarket clinical studies submitted to the food and drug administration 2000–2007. Am J Ther 17 2 7