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

Abstract

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.

Keywords

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

Notes

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.

References

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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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