By using this site, you agree to the Privacy Policy and Terms of Use.
Accept
Health Works CollectiveHealth Works CollectiveHealth Works Collective
  • Health
    • Mental Health
    Health
    Healthcare organizations are operating on slimmer profit margins than ever. One report in August showed that they are even lower than the beginning of the…
    Show More
    Top News
    bowl of vegetable salad
    Raw Foods: benefits and harms
    November 9, 2021
    pros and cons of the keto diet
    Read This Before You Follow the Keto Diet
    May 18, 2022
    spinal cord injuries
    4 Potential Causes of Spinal Cord Injuries (and How to Seek Compensation)
    May 25, 2022
    Latest News
    7 Most Common Healthcare Accreditation Programs: Which Should You Use?
    August 20, 2025
    Hospital Pest Control and the Fight Against Superbugs
    August 20, 2025
    Hygiene Beyond The Clinic: Attention To Overlooked Non-Clinical Spaces
    August 13, 2025
    5 Steps to a Promising Career as a Healthcare Administrator
    August 3, 2025
  • Policy and Law
    • Global Healthcare
    • Medical Ethics
    Policy and Law
    Get the latest updates about Insurance policies and Laws in the Healthcare industry for different geographical locations.
    Show More
    Top News
    TBI: Some Surprising Statistics
    February 9, 2016
    Your Keys to Safer, Even More Secure Healthcare Cloud Services
    January 13, 2015
    4 Career Options in Healthcare Industry that Combine Big Data & Healthcare
    February 5, 2021
    Latest News
    How Social Security Disability Shapes Access to Care and Everyday Health
    August 22, 2025
    How a DUI Lawyer Can Help When Your Future Health Feels Uncertain
    August 22, 2025
    How One Fall Can Lead to a Long Road of Medical Complications
    August 22, 2025
    How IT and Marketing Teams Can Collaborate to Protect Patient Trust
    July 17, 2025
  • Medical Innovations
  • News
  • Wellness
  • Tech
Search
© 2023 HealthWorks Collective. All Rights Reserved.
Reading: Medical Device Approval Process is Faulted in Study
Share
Notification Show More
Font ResizerAa
Health Works CollectiveHealth Works Collective
Font ResizerAa
Search
Follow US
  • About
  • Contact
  • Privacy
© 2023 HealthWorks Collective. All Rights Reserved.
Health Works Collective > Technology > Medical Devices > Medical Device Approval Process is Faulted in Study
BusinessMedical Devices

Medical Device Approval Process is Faulted in Study

GlennLaffel
GlennLaffel
Share
4 Min Read
SHARE

More than 70% of all medical devices that have been recalled by the FDA for safety concerns were not subjected to rigorous clinical testing before the agency approved them, according to a new study.

The study authors were Diana Zuckerman and Paul Brown from the National Research Center for Women and Families, a consumer group, and Steven Nissen, a cardiologist at Cleveland Clinic.

The authors reported that overall, the FDA recalled 113 medical devices between 2005 and 2009. Of these, 21 had been approved on the basis of rigorous clinical trial data. Eighty others had been approved under a less stringent, expedited approval process known as 510K, in which a device maker needs only to show that its new product is substantially similar to one already on the market. An additional 8 devices were exempt from FDA regulations, and 4 more were either counterfeit or classified as “other.”

More Read

Primary Care Workforce Shortage: Possible Solutions
A Culture of Safety in Hospitals and the CEO’s Role
Are Radiologists Not Getting Paid for ED Procedures?
Medical Device Tax Costs 1,000 Jobs
How Merck’s Jain is Helping Pharma Catch up to the Digital Health Movement

Devices approved using the 510K approval process included mechanical ventilators, insulin infusion pumps, artificial hips and knees, and external cardiac defibrillators. The more rigorous process is typically reserved for life-supporting devices like implanted cardiac defibrillators. In the latter process, device makers must sponsor trials designed to prove their products are safe and effective.

Last summer, the FDA announced it was implementing some steps to “strengthen” the 510K process, but it deferred on a complete overhau pending the release of a report on the matter by the Institute of Medicine. The report is due later this year. In an interview, Zuckerman said her group’s findings suggest that the FDA’s actions to date on 510K aren’t adequate. Device manufacturers have managed to expand the concept of “similar” well beyond the FDA’s original intent when the 510K law went live in 1976, Zuckerman explained. “The law has gotten looser and looser over time.”

The FDA blew-off Zuckerman’s findings as old news. According to a statement by the agency, the data had been presented by Zuckerman last year at a public meeting sponsored by the IOM.

For its part, the Advanced Medical Technology Association, a device industry trade group, said the study was misleading. It wasn’t surprising that 510K-approved devices accounted for most of the recalls, the group said, because most FDA-approved devices have gone through the 510K process.

Stephen Ubl, the Association’s CEO added that the study was “fundamentally flawed” since it focused “on the total number of recalls and ignored the fact that there are over 50,000 devices on the market.”

Ubl added that the percentage of products recalled for serious health problems or deaths was substantially below 1%. He added that an overly strict regulatory process would hinder innovation and prompt device manufacturers to move product development to other countries where regulatory scrutiny isn’t as intense.

Zuckerman’s write-up appears in the Archives of Internal Medicine.

TAGGED:FDAmedical devices
Share This Article
Facebook Copy Link Print
Share

Stay Connected

1.5kFollowersLike
4.5kFollowersFollow
2.8kFollowersPin
136kSubscribersSubscribe

Latest News

engineer fitting prosthetic arm
How Social Security Disability Shapes Access to Care and Everyday Health
Health care
August 20, 2025
a woman explaining the document
How a DUI Lawyer Can Help When Your Future Health Feels Uncertain
Public Health
August 20, 2025
physiotherapist at work
How One Fall Can Lead to a Long Road of Medical Complications
Health care
August 20, 2025
Common Healthcare Accreditation Programs
7 Most Common Healthcare Accreditation Programs: Which Should You Use?
Health News
August 20, 2025

You Might also Like

Readmission Reduction Program
BusinessFinanceHealth ReformPolicy & LawPublic Health

9 Criticisms of the Readmission Reduction Program

June 6, 2014
anthem logo
BusinessNewsPolicy & LawTechnology

Blue Cross Blue Shield Provider Anthem Hacked

February 11, 2015
brave leaving comfort zone
BusinessHospital Administration

Is Your Hospital Brave Enough to Publish Online Physician Reviews?

March 25, 2016
Observation Units
BusinessFinanceHospital Administration

Observation Units: Bridging the Gap Between Inpatient and Outpatient

April 7, 2014
Subscribe
Subscribe to our newsletter to get our newest articles instantly!
Follow US
© 2008-2025 HealthWorks Collective. All Rights Reserved.
  • About
  • Contact
  • Privacy
Welcome Back!

Sign in to your account

Username or Email Address
Password

Lost your password?