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Journal of General Internal Medicine

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Open Access 01-01-2008 | Perspectives

Who is Responsible for Evaluating the Safety and Effectiveness of Medical Devices? The Role of Independent Technology Assessment

Authors: Mitchell D. Feldman, MD, MPhil, Amy J. Petersen, PhD,MFA, Leah S. Karliner, MD, Jeffrey A. Tice, MD

Published in: Journal of General Internal Medicine | Special Issue 1/2008

Abstract

Introduction

The global medical technology industry brings thousands of devices to market every year. However, significant gaps persist in the scientific literature, in the medical device approval process, and in the realm of postmarketing surveillance. Although thousands of drugs obtain approval only after review in randomized controlled trials, relatively few new medical devices are subject to comparable scrutiny.

Objective

To improve health outcomes, we must enhance our scrutiny of medical devices, and, without simply deferring to the Food and Drug Administration, we must ask ourselves: Who is responsible for evaluating the safety and effectiveness of medical devices?

Conclusions

Technology assessments by independent organizations are a part of the solution to this challenge and may motivate further research focused on patient outcomes.

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Title: Who is Responsible for Evaluating the Safety and Effectiveness of Medical Devices? The Role of Independent Technology Assessment
Authors: Mitchell D. Feldman, MD, MPhil
Amy J. Petersen, PhD,MFA
Leah S. Karliner, MD
Jeffrey A. Tice, MD
Publication date: 01-01-2008
Publisher: Springer-Verlag
Published in: Journal of General Internal Medicine / Issue Special Issue 1/2008
Print ISSN: 0884-8734
Electronic ISSN: 1525-1497
DOI: https://doi.org/10.1007/s11606-007-0275-4

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Abstract

Introduction

Objective

Conclusions

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