Strength of study evidence examined by the FDA in premarket approval of cardiovascular devices

JAMA

Volumn 302, Issue 24, 2009, Pages 2679-2685

  Dhruva, Sanket S ^a   Bero, Lisa A ^a,b   Redberg, Rita F ^a,b  

^a UNIVERSITY OF CALIFORNIA   (United States)

^b UNIVERSITY OF CALIFORNIA   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CARDIOVASCULAR EQUIPMENT; DATA ANALYSIS; EVIDENCE BASED PRACTICE; FOOD AND DRUG ADMINISTRATION; HUMAN; PRIORITY JOURNAL; REVIEW; SAFETY; SYSTEMATIC REVIEW; BIOASSAY; CARDIOLOGY; CLINICAL TRIAL; EPIDEMIOLOGY; EQUIPMENT; INSTRUMENTATION; UNITED STATES;

BIAS (EPIDEMIOLOGY); CARDIOLOGY; CLINICAL TRIALS AS TOPIC; DEVICE APPROVAL; ENDPOINT DETERMINATION; EQUIPMENT SAFETY; HUMANS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 73949084847     PISSN: 00987484     EISSN: 15383598     Source Type: Journal    
DOI: 10.1001/jama.2009.1899     Document Type: Review

References (40)

1. Muni NI, Zuckerman BD. The process of regulatory review for new cardiovascular devices. In: Antman EM, ed. Cardiovascular Therapeutics: A Companion to Braunwald's Heart Disease, 3rd Edition. Philadelphia, PA: Elsevier; 2007.
2. Zhan C, Baine WB, Sedrakyan A, Steiner C. Cardiac device implantation in the United States from 1997 through 2004: a population-based analysis. J Gen Intern Med. 2007;23(suppl 1):13-19.
3. Rising K, Bacchetti P, Bero L. Reporting bias in drug trials submitted to the Food and Drug Administration: review of publication and presentation. PLoS Med. 2008;5(11):e217.
4. Feigal DW, Gardner SN, McClellan M. Ensuring safe and effective medical devices. N Engl J Med. 2003;348(3):191-192.
5. Medical Device User Fee and Modernization Act of 2002 frequently asked questions. US Food and Drug Administration. http://www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance/Overview/ MedicalDeviceUserFeeandModernizationActMDUFMA/ucm109208.htm. Accessed July 22, 2009.
6. Maisel WH. Medical device regulation: an introduction for the practicing physician. Ann Intern Med. 2004;140(4):296-302.
7. Device classes: general and special controls. US Food and Drug Administration. http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/ Overview/GeneralandSpecialControls/default.htm. Accessed July 22, 2009.
8. Premarket Approval device advice: overview. US Food and Drug Administration. http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/ HowtoMarketYourDevice/PremarketSubmissions/PremarketApprovalPMA/default.htm. Accessed July 22, 2009.
9. Testimony on FDA's medical device program by Michael Friedman, MD, lead deputy commissioner, US Food and Drug Administration, before the House Committee on Commerce, Subcommittee on Health and the Environment [April 30, 1997]. http://www.dhhs.gov/asl/testify/t970430a.html. Accessed July 22, 2009.
10. Yock CA, Yock PG. The drug-eluting stent information gap. Am Heart Hosp J. 2004;2(1):21-25.
11. Boden WE, Diamond GA. DTCA for PTCA: crossing the line in consumer health education? N Engl J Med. 2008;358(21):2197-2200.
12. Mitka M. Direct-to-consumer advertising of medical devices under scrutiny. JAMA. 2008;300(17):1985-1986.
13. Gostin LO. The deregulatory effects of preempting tort litigation: FDA regulation of medical devices. JAMA. 2008;299(19):2313-2316.
14. Assessing risk of bias in included studies. Higgins JPT, Altman DG, eds. In: Higgins JPT, Green S, eds. Cochrane Handbook for Systematic Reviews of Interventions. http://www.cochrane-handbook.org. Accessed July 22, 2009.
15. PMA application contents: summary of safety and effectiveness data. US Food and Drug Administration. http://www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/ PremarketApprovalPMA/ucm050289.htm#ssed. Accessed July 22, 2009.
16. Premarket approval: Center for Devices and Radiological Health SuperSearch. US Food and Drug Administration. http://www.accessdata.fda.gov/ scripts/cdrh/cfdocs/cfPMA/pma.cfm. Accessed December 1, 2009.
17. Summary of safety and effectiveness data: PMA No. 040036, NaviStar ThermoCool deflectable diagnostic/ablation catheter [August 2006]. http://www.accessdata.fda.gov/cdrh-docs/pdf4/P040036b.pdf. Accessed July 22, 2009.
18. Summary of safety and effectiveness data: PMA No. 020045, cardiac cryoablation catheter and console system. http://www.accessdata.fda.gov/cdrh- docs/pdf2/P020045b.pdf. Accessed November 8, 2009.
19. Fleming TR, DeMets DL. Surrogate end points in clinical trials: are we being misled? Ann Intern Med. 1996;125(7):605-613.
20. Lim E, Brown A, Helmy A, Mussa S, Altman DG. Composite outcomes in cardiovascular research: a survey of randomized trials. Ann Intern Med. 2008;149(9):612-617.
21. Food and drugs: premarket approval of medical devices: research conducted outside the United States. 21 CFR §814.15.
22. Glickman SW, McHutchinson JG, Peterson ED, et al. Ethical and scientific implications of the globalization of clinical research. N Engl J Med. 2009;360(8):816-823.
23. Emanuel EJ, Fuchs VR. The perfect storm of overutilization. JAMA. 2008;299(23):2789-2791.
24. Maisel WH. Semper fidelis: consumer protection for patients with implanted medical devices. N Engl J Med. 2008;358(10):985-987.
25. Medtronic recalls Sprint Fidelis cardiac leads: questions and answers for consumers. US Food and Drug Administration. http://www.fda.gov/ForConsumers/ ConsumerUpdates/ucm103022.htm. Accessed November 22, 2009.
26. Wyeth v Levine, 555 US -- (2009).
27. Curfman GD, Morrissey S, Drazen JM. The Medical Device Safety Act of 2009. N Engl J Med. 2009;360(15):1550-1551.
28. Meier B. Maker of heart device kept flaw from doctors. The New York Times. May 24, 2005:1.
29. Maisel WH. Safety issues involving medical devices: implications of recent implantable cardioverter-defibrillator malfunctions. JAMA. 2005;294(8):955-958.
30. Douglas PS, Brennan JM, Anstrom KJ, et al. Clinical effectiveness of coronary stents in elderly persons: results from 262,700 Medicare patients in the American College of Cardiology-National Cardiovascular Data Registry. J Am Coll Cardiol. 2009;53(18):1629-1641.
31. Feldman MD, Petersen AJ, Karliner LS, Tice JA. Who is responsible for evaluating the safety and effectiveness of medical devices? the role of independent technology assessment. J Gen Intern Med. 2008;23(suppl 1):57-63.
32. Furlan AJ, Fisher M. Devices, drugs, and the Food and Drug Administration: increasing implications for ischemic stroke. Stroke. 2005;36(2):398-399.
33. National health expenditures: 2007 highlights. http://www.cms.hhs.gov/ NationalHealthExpendData/downloads/highlights.pdf. Accessed July 22, 2009.
34. Technological change and the growth of health care spending: January 2008. Congressional Budget Office. http://www.cbo.gov/doc.cfm?index=8947. Accessed December 2, 2009.
35. Orszag PR, Ellis P. Addressing rising health care costs: a view from the Congressional Budget Office. N Engl J Med. 2007;357(19):1885-1887.
36. Comparative effectiveness research in the USA. Lancet. 2009;373(9665):694.
37. Alexander GC, Stafford RS. Does comparative effectiveness have a comparative edge? JAMA. 2009;301(23):2488-2490.
38. Mongan JJ, Ferris TG, Lee TH. Options for slowing the growth of health care costs.N Engl J Med. 2008;358(14):1509-1514.
39. Iglehart JK. Prioritizing comparative-effectiveness research: IOM recommendations. N Engl J Med. 2009;361(4):325-328.
40. O'Connor AB. The need for improved access to FDA reviews. JAMA. 2009;302(2):191-193.