US regulation of medical devices "flawed," report says

Vogel, Lauren
September 2011
CMAJ: Canadian Medical Association Journal;9/6/2011, Vol. 183 Issue 12, pE796
Academic Journal
The article focuses on the July 29, 2011 report by the U.S. Institute of Medicine (IOM) which suggests for the elimination of the fast-track process by the U.S. government used for vetting medical devices due to its lack of ability to insure products' efficacy and safety.


Related Articles

  • Industry Leaders Choose Sides Over IOM's 510(k) Report.  // Orthopedic Design & Technology;Sep/Oct2011, Vol. 7 Issue 5, p18 

    The article reports that leaders in the U.S. medical instruments and apparatus industry have sought for an updated clearance process from the 510(k) study of the Institute of Medicine (IOM). It notes that maintenance and encouragement of medical device innovation are aimed by the 510(k) process....

  • Report finds FDA oversight lacking on pediatric devices.  // Materials Management in Health Care;Sep2005, Vol. 14 Issue 9, p12 

    Reports on the findings of the study conducted by the Institute of Medicine (IOM), a nonprofit institution, which addresses the efficiency of the U.S. Food and Drug Administration (FDA). Comments of IOM on the administration's lack of effective procedures to monitor post-market safety studies of...

  • Safety Testing: Moving Toward Alternative Methods. Birnbaum, Linda S.; Stokes, William S. // Environmental Health Perspectives;Jan2010, Vol. 118 Issue 1, pA12 

    The authors reflect on the need to develop alternative toxicity testing methods. They state that the U.S. Institute of Medicine reported poisoning as the second leading cause of injury-related deaths. They note that the Interagency Coordinating Committee on the Validation of Alternative Methods...

  • FDA says device process should remain. Arnold, Matthew // Medical Marketing & Media;Sep2011, Vol. 46 Issue 9, p14 

    The article reports on the stand of the U.S. Food and Drug Administration (FDA) on their approval process for medical devices. It relates that despite of the call by the Institute of Medicine (IOM) to scrap the process of approving many of medical devices, FDA is firmed that the process should...

  • Start from scratch. Kondro, Wayne // CMAJ: Canadian Medical Association Journal;10/4/2011, Vol. 183 Issue 14, pE1051 

    The article reports that the U.S. Institute of Medicine argues that the machinery of the U.S. Food and Drug Administration's process for regulating moderate risk medical devices completely fails to examine the efficacy and safety of the devices before they are put on the market.

  • IOM Report Urges FDA to Scrap 510(k) Process. Sprovieri, John // Assembly;Sep2011, Vol. 54 Issue 9, p14 

    The article discusses a report that urges the U.S. Food and Drug Administration (FDA) to develop a new regulatory framework to replace the 510 (k) clearance process for moderate-risk medical devices. The report issued by the Institute of Medicine, a nonprofit advisory organization, claims that...

  • Guidelines may be the single instrument for evaluation of professional conduct? Massoni, Francesco; Ricci, Pasquale; Ricci, Seraino // HealthMed;2014, Vol. 8 Issue 5, p588 

    The guidelines are recommendations for the health care worker behavior. However in Italy the L. 189/2012 has linked the professional responsibility to respect these without reference to the quality of the guidelines accessible. The authors proceed to an analysis of the literature using as a...

  • Time to Scrap the U.S. System of Medical Device Regulation? Wiederhold, Brenda K. // CyberPsychology, Behavior & Social Networking;Mar2012, Vol. 15 Issue 3, p127 

    The author reflects on a report of a U.S. Institute of Medicine (IOM) panel on the abandonment of the U.S. Food and Drug Administration (FDA) on its 35-year-old process of clearing medical device. She states that the process is inadequate for patient's protection and that FDA is slow in the...

  • Knowing the Pain Points. Anderson, Larry // HomeCare Magazine;May2013, Vol. 36 Issue 5, p36 

    The article focuses on the pain management sales by home medical equipment (HME)/ durable medical equipment (DME) providers. It states that pain management offers the potential for growth in cash sales. It discusses the report "Relieving pain in America" of the U.S. Institute of Medicine on...


Read the Article


Sorry, but this item is not currently available from your library.

Try another library?
Sign out of this library

Other Topics