Skip to main content

Advertisement

SpringerLink
Log in

FDA regulation of cardiovascular devices and opportunities for improvement

  • Published:
Journal of Interventional Cardiac Electrophysiology Aims and scope Submit manuscript

Abstract

Medical devices are of increasing importance in cardiovascular disease and have made important contributions to patient care. These devices continue to evolve with increasing complexity. FDA regulation of medical devices involves increased stringency for higher risk and novel devices. However, there are some current opportunities to strengthen the FDA’s pre-approval regulatory process and improve post-marketing surveillance. This article reviews FDA regulation of cardiovascular devices and offers suggestions for strengthening the process while focusing on examples relevant to cardiac electrophysiologists.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Similar content being viewed by others

References

  1. Mond, H. G., & Proclemer, A. (2011). The 11th world survey of cardiac pacing and implantable cardioverter-defibrillators: calendar year 2009—a world society of arrhythmia’s project. PACE, 34, 1013–1027.

    Article  PubMed  Google Scholar 

  2. Feigal, D. W., Gardner, S. N., & McClellan, M. (2003). Ensuring safe and effective medical devices. The New England Journal of Medicine, 348(3), 191–192.

    Article  PubMed  Google Scholar 

  3. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER). (1998). Guidance for Industry Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products. Rockville: CDER and CBER.

    Google Scholar 

  4. Garber, A. M. (2010). Modernizing device regulation. The New England Journal of Medicine, 362(13), 1161–1163.

    Article  PubMed  CAS  Google Scholar 

  5. Food, Drug, and Cosmetic Act. 21 USC § 201(h). http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/. Accessed 19 Nov 2012.

  6. The Least Burdensome Provisions of the FDA Modernization Act of 1997: Concept and Principles; Final Guidance for FDA and Industry. http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm085994.htm. Accessed 19 Nov 2012.

  7. Department of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health, Center for Biologics Evaluation and Research. Guidance for Industry and Food and Drug Administration Staff Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications. March 28, 2012. http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM296379.pdf. Accessed 19 Nov 2012.

  8. U.S. Food and Drug Administration, Center for Devices and Radiological Health. Device Classes. http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/GeneralandSpecialControls/default.htm. Accessed 19 Nov 2012.

  9. US Government Accountability Office. FDA should take steps to ensure that high-risk device types are approved through the most stringent premarket review process: GAO-09-190: January 2009. http://gao.gov/new.items/d09190.pdf. Accessed 19 Nov 2012.

  10. U.S. Food and Drug Administration. Medical Devices: Premarket Notification (510 k). http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/default.htm. Accessed 19 Nov 2012.

  11. Chen, E. A., Patel-Raman, S. M., O’Callaghan, K., & Hillebrenner, M. G. (2009). FDA’s perspectives on cardiovascular devices. Journal of Cardiovascular Translational Research, 2(2), 143–146.

    Article  PubMed  CAS  Google Scholar 

  12. U.S. Food and Drug Administration. Medical Devices: PMA Application Contents. http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketApprovalPMA/ucm050289.htm. Accessed 19 Nov 2012.

  13. O’Connor, A. B. (2009). The need for improved access to FDA reviews. JAMA: The Journal of the American Medical Association, 302(2), 191–193.

    Article  Google Scholar 

  14. Asamoah, A. K., & Sharfstein, J. M. (2010). Transparency at the food and drug administration. The New England Journal of Medicine, 362, 2341–2343.

    Article  PubMed  CAS  Google Scholar 

  15. Redberg, R. F. (2010). Medical devices and the FDA approval process: balancing safety and innovation; comment on “Prevalence of fracture and fragment embolization of bard retrievable vena cava filters and clinical implications including cardiac perforation and tamponade”. Archives of Internal Medicine, 170(20), 1831–1833.

    Article  PubMed  Google Scholar 

  16. Nicholson, W., Nicholson, W. J., Tolerico, P., Taylor, B., Solomon, S., Schryver, T., McCullum, K., Goldberg, H., Mills, J., Schuler, B., Shears, L., Siddoway, L., Agarwal, N., & Tuohy, C. (2010). Prevalence of fracture and fragment embolization of bard retrievable vena cava filters and clinical implications including cardiac perforation and tamponade. Archives of Internal Medicine, 170(20), 1827–1831.

    Article  PubMed  Google Scholar 

  17. Food and Drug Administration. Removing Retrievable Inferior Vena Cava Filters: Initial Communication. August 9, 2010. http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm221676.htm. Accessed 19 Nov 2012.

  18. Institute of Medicine. (2011). Medical devices and the public’s health: the FDA 510(k) clearance process at 35 years. Washington: National Academies Press.

    Google Scholar 

  19. Challoner, D. R., & Vodra, W. W. (2011). Medical devices and health—creating a new regulatory framework for moderate-risk devices. The New England Journal of Medicine, 365, 977–979.

    Article  PubMed  CAS  Google Scholar 

  20. Curfman, G. D., & Redberg, R. F. (2011). Medical devices—balancing regulation and innovation. The New England Journal of Medicine, 365, 975–977.

    Article  PubMed  CAS  Google Scholar 

  21. Redberg, R. F., & Dhruva, S. S. (2011). Medical device recalls: get it right the first time: comment on “Medical device recalls and the FDA approval process”. Archives of Internal Medicine, 171, 1011–1012.

    Article  PubMed  Google Scholar 

  22. Dhruva, S. S., Bero, L. A., & Redberg, R. F. (2009). Strength of study evidence examined by the FDA in premarket approval of cardiovascular devices. JAMA: The Journal of the American Medical Association, 302, 2679–2685.

    Article  CAS  Google Scholar 

  23. Lim, E., Brown, A., Helmy, A., Mussa, S., & Altman, D. G. (2008). Composite outcomes in cardiovascular research: a survey of randomized trials. Annals of Internal Medicine, 149(9), 612–617.

    PubMed  Google Scholar 

  24. Makower J, Meer A, Denend L. FDA Impact on U.S. Medical technology innovation: a survey of over 200 medical technology companies. November 2010.

  25. Cohen, D., & Billingsley, M. (2011). Europeans are left to their own devices. BMJ, 342, d2748.

    Article  PubMed  Google Scholar 

  26. Chen, C. E., Dhruva, S. S., Bero, L. A., & Redberg, R. F. (2011). Inclusion of training patients in US food and drug administration premarket approval cardiovascular device studies. Archives of Internal Medicine, 171(6), 534–539.

    Article  PubMed  Google Scholar 

  27. Maisel, W. B. (2009). Left atrial appendage occlusion—closure or just the beginning? The New England Journal of Medicine, 360, 2601–2603.

    Article  PubMed  CAS  Google Scholar 

  28. Mack, M. J., & Holmes, D. R. (2011). Rational dispersion for the introduction of transcatheter valve therapy. JAMA: The Journal of the American Medical Association, 306(19), 2149–2150.

    Article  CAS  Google Scholar 

  29. Okie, S. (2010). Reviving the FDA. The New England Journal of Medicine, 363, 1492–1494.

    Article  PubMed  Google Scholar 

  30. Zuckerman, D. M., Brown, P., & Nissen, S. E. (2011). Medical device recalls and the FDA approval process. Archives of Internal Medicine, 171, 1006–1011.

    Article  PubMed  Google Scholar 

  31. Maisel, W. H. (2008). Semper fidelis—consumer protection for patients with implanted medical devices. The New England Journal of Medicine, 358, 985–987.

    Article  PubMed  CAS  Google Scholar 

  32. Yeh, R. W., Kennedy, K., Spertus, J. A., Parikh, S. A., Sakhuja, R., Anderson, H. V., White, C. J., & Rosenfield, K. (2011). Do postmarketing surveillance studies represent real-world populations? A comparison of patient characteristics and outcomes after carotid artery stenting. Circulation, 123, 1384–1390.

    Article  PubMed  Google Scholar 

  33. Lenzer, J., & Brownlee, S. (2010). Why the FDA can’t protect the public. BMJ, 341, c4753.

    Article  PubMed  Google Scholar 

  34. Maisel, W. H. (2005). Safety issues involving medical devices: implications of recent implantable cardioverter-defibrillator malfunctions. JAMA: The Journal of the American Medical Association, 294, 955–958.

    Article  CAS  Google Scholar 

  35. Hauser, R. G. (2012). Here we go again—another failure of postmarketing device surveillance. The New England Journal of Medicine, 366, 873–875.

    Article  PubMed  CAS  Google Scholar 

  36. FDA Safety Communication: Premature insulation failure in recalled riata implantable cardioverter defibrillator (ICD) leads manufactured by St. Jude Medical, Inc. http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm314930.htm. Accessed 19 Nov 2012.

  37. US Government Accountability Office. FDA Should Enhance Its Oversight of Recalls. GAO-11-468. June 2011. www.gao.gov/new.items/d11468.pdf. Accessed 19 Nov 2012.

  38. Resnic, F. S., Gross, T. P., Marinac-Dabic, D., Loyo-Berrios, N., Donnelly, S., Normand, S. L., & Matheny, M. E. (2010). Automated surveillance to detect postprocedure safety signals of approved cardiovascular devices. JAMA: The Journal of the American Medical Association, 304, 2019–2027.

    Article  CAS  Google Scholar 

  39. Behrman, R. E., Benner, J. S., Brown, J. S., McClellan, M., Woodcock, J., & Platt, R. (2011). Developing the sentinel system—a national resource for evidence development. The New England Journal of Medicine, 364(6), 498–499.

    Article  PubMed  CAS  Google Scholar 

  40. Curfman, G. D., Morrissey, S., & Drazen, J. D. (2009). The medical device safety Act of 2009. The New England Journal of Medicine, 360, 1550–1551.

    Article  PubMed  CAS  Google Scholar 

  41. Gostin, L. O. (2008). The deregulatory effects of preempting tort litigation: FDA regulation of medical devices. JAMA: The Journal of the American Medical Association, 299, 2313–2316.

    Article  CAS  Google Scholar 

  42. Dhruva, S. S., Bero, L. A., & Redberg, R. F. (2011). Gender bias in studies for food and drug administration premarket approval of cardiovascular devices. Circulation Cardiovascular Quality and Outcomes, 4, 165–171.

    Article  PubMed  Google Scholar 

  43. Summary of Safety and Effectiveness. PMA 000009. Phylax AV ICD, Model 122 382, Software Cartridge SWMI/I-GAV.2.U, Model 128 814. September 2000. http://www.accessdata.fda.gov/cdrh_docs/pdf/P000009b.pdf. Accessed 19 Nov 2012.

  44. Kim, E. S., & Menon, V. (2009). Status of women in cardiovascular clinical trials. Arteriosclerosis, Thrombosis, and Vascular Biology, 29, 279–283.

    Article  PubMed  CAS  Google Scholar 

  45. Ghanbari, H., Dalloul, G., Hasan, R., Daccarett, M., Saba, S., David, S., & Machado, C. (2009). Effectiveness of implantable cardioverter defibrillators for primary prevention of sudden cardiac death in women with advanced heart failure: a meta-analysis of randomized controlled trials. Archives of Internal Medicine, 169, 1500–1506.

    Article  PubMed  Google Scholar 

  46. Redberg, R. F. (2009). Is what is good for the gander really good for the goose? Archives of Internal Medicine, 169, 1460–1461.

    Article  PubMed  Google Scholar 

  47. Peterson, P. N., Daugherty, S. L., Wang, Y., Vidaillet, H. J., Heidenreich, P. A., & Curtis, J. P. (2009). Masoudi FA on behalf of the national cardiovascular data registry. Gender differences in procedure-related adverse events in patients receiving implantable cardioverter-defibrillator therapy. Circulation, 119, 1078–1084.

    Article  PubMed  Google Scholar 

  48. Arshad, A., Moss, A. J., Foster, E., Padeletti, L., Barsheshet, A., Goldenberg, I., et al. (2011). Cardiac resynchronization therapy is more effective in women than in men: the MADIT-CRT (Multicenter Automatic Defibrillator Implantation Trial with Cardiac Resynchronization Therapy) Trial. Journal of the American College of Cardiology, 57(7), 813–820.

    Article  PubMed  Google Scholar 

  49. Draft Guidance for Industry and Food and Drug Adminsitration Staff: Evaluation of Sex Differences in Medical Device Clinical Studies. http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm283453.htm. Accessed 19 Nov 2012.

  50. Dhruva, S. S., & Redberg, R. F. (2010). Accelerated approval and possible withdrawal of midodrine. JAMA: The Journal of the American Medical Association, 304, 2172–2173.

    Article  CAS  Google Scholar 

Download references

Conflict of interest

Dr. Redberg reports being a member of the FDA Circulatory System Devices Panel.

Author information

Authors and Affiliations

  1. Department of Internal Medicine, Division of Cardiology, University of California, Davis, CA, USA

    Sanket S. Dhruva

  2. UCSF Department of Medicine, Division of Cardiology, 505 Parnassus Ave., Suite M-1180, San Francisco, CA, 94143-0124, USA

    Rita F. Redberg

Authors
  1. Sanket S. Dhruva
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Rita F. Redberg
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Rita F. Redberg.

Rights and permissions

Reprints and permissions

About this article

Cite this article

Dhruva, S.S., Redberg, R.F. FDA regulation of cardiovascular devices and opportunities for improvement. J Interv Card Electrophysiol 36, 99–105 (2013). https://doi.org/10.1007/s10840-012-9767-1

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s10840-012-9767-1

Keywords

Search

Navigation