Overview of the US FDA Medical Device Approval Process

New Therapies for Cardiovascular Disease (KW Mahaffey, Section Editor)
Part of the following topical collections:
  1. Topical Collection on New Therapies for Cardiovascular Disease


Increasing barriers to medical device innovation in the United States including constrained financial resources and rising research costs require that physicians take on greater involvement in medical device development, evaluation, and regulatory processes. Such involvement requires that physicians understand basic aspects of the regulatory process for medical devices and recognize the myriad opportunities for involvement in these activities.


FDA Medical device Approval Regulatory PMA IDE 510(k) HDE CDRH MAUDE Safety monitoring Pivotal study 


Compliance with Ethics Guidelines

Conflict of Interest

Ashwani Sastry declares that he has no conflict of interest.

Human and Animal Rights and Informed Consent

This article does not contain any studies with human or animal subjects performed by any of the authors.


Papers of particular interest, published recently, have been highlighted as: • Of importance

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    FDA's Medical Device Program 2013: Looking Back and Looking Ahead. Available at http://xavierhealth.org/wp-content/uploads/7.-Shuren_FDA-Update.pdf.
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    Kaplan AV, Harvey ED, Kuntz RE, et al. Humanitarian Use Devices/Humanitarian Device Exemptions in cardiovascular medicine. Circulation. 2005;112(18):2883–6.PubMedCrossRefGoogle Scholar
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    FDA Guidance Document: Investigational Device Exemptions (IDEs) for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human (FIH) Studies. Available at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM279103.pdf. This Guidance document represents a signficiant step toward bringing early feasibility studies back into the United States.
  4. 4.
    Medical Device Innovation Initiative White Paper: CDRH Innvovation Initiative. Available at http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHInnovation/ucm242067.htm.
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    Mauri L, Garg P, Massaro JM, et al. The EVEREST II Trial: design and rationale for a randomized study of the evalve mitraclip system compared with mitral valve surgery for mitral regurgitation. Am Heart J. 2010;160(1):23–9.PubMedCrossRefGoogle Scholar
  7. 7.
    Draft Guidance Document: Heart Valves - Investigational Device Exemption (IDE) and Premarket Approval (PMA) Applications. Available at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM198043.pdf.
  8. 8.
    Krucoff MW, Brindis RG, Hodgson PK, et al. Medical device innovation: prospective solutions for an ecosystem in crisis. Adding a professional society perspective. JACC Cardiovasc Interv. 2012;5(7):790–6.PubMedCrossRefGoogle Scholar

Copyright information

© Springer Science+Business Media New York 2014

Authors and Affiliations

  1. 1.New York Presbyterian HospitalColumbia University Medical CenterNew YorkUSA

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