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
    physical health
    5 Ways Playing Games Can Improve Neural and Physical Health
    September 9, 2022
    Reasons For Hair Loss and Its Treatment
    Reasons For Hair Loss and Its Treatment
    February 16, 2022
    healthcare organization
    5 Actionable Strategies For Healthcare Organizations
    August 15, 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
    Almost Anybody Qualifies for Medicaid in Maine
    November 23, 2012
    ebola and EHR
    Ebola: Are We Relying on EHR to Tell the Story?
    October 24, 2014
    Caitlin Kelly
    How Would You Fix Healthcare? – Question and Answers.
    January 16, 2013
    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: Alternatives to Scrapping 510(k)
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 > Alternatives to Scrapping 510(k)
Medical DevicesTechnology

Alternatives to Scrapping 510(k)

gooznews
gooznews
Share
4 Min Read
SHARE

The Institute of Medicine report on medical device regulation released two weeks ago called for scrapping the 510(k) process that allows for market entry of new devices if they’re shown to be “substantially equivalent” to already marketed devices. In a Perspective in today’s New England Journal of Medicine, committee members David R. Challoner, M.D. of the University of Florida and William W.

The Institute of Medicine report on medical device regulation released two weeks ago called for scrapping the 510(k) process that allows for market entry of new devices if they’re shown to be “substantially equivalent” to already marketed devices. In a Perspective in today’s New England Journal of Medicine, committee members David R. Challoner, M.D. of the University of Florida and William W. Vodra, J.D., an attorney at Arnold & Porter, reiterated the reasoning of the report:

Today, we have a system in which a new moderate-risk device can enter the market because it is substantially equivalent to another device that may have been cleared for marketing 2 years ago because its manufacturer showed that it was substantially equivalent to yet another device cleared in 2003, and so on, all the way back to a device that was being marketed when the law was enacted in 1976. But that original device might never have been assessed for safety or effectiveness, nor perhaps would any subsequent ones in the family tree. . . We decided that the 510(k) process cannot be transformed into a premarketing evaluation of safety and effectiveness as long as the standard for clearance is substantial equivalence to a previously cleared device.

Alas, the Food and Drug Administration immediately rejected the committee’s conclusion that the entire process be scrapped. In a second Perspective,  Gregory D. Curfman, M.D., and Rita F. Redberg, M.D., editors at NEJM and the Archives of Internal Medicine, respectively, lamented the FDA’s position and offered an alternative approach. They wrote:

  • The 510(k) process, if not abolished entirely, should at least never be used in class III devices, defined as those whose failure would pose an immediate risk to health or safety. These would include most implanted orthopedic and cardiovascular devices that are of most concern;
  • Ban the use of multiple predicate devices; and
  • Adopt a formal system of postmarketing surveillance for medical devices that includes registries to track device performance and their medical outcomes, careful tracking of patients, and mandatory disclosure of postmarketing safety data.

The FDA shouldn’t cave into industry pressure to abandon the report. The agency should use it as a stepping stone to adopting reforms along the lines recommended by Curfman and Redberg.

More Read

Digitized Pathology Improves Study Results and Cuts Costs
A Healthier Conversation
The Consumer-Driven, Digital Disruption in Healthcare
Who’s Who of Health Care Join Forces for SMART Technology
X-rays and Mom — Case Study into the State of Imaging Technology

Collection of comprehensive data on device performance will have ramifications far beyond the safety issues that triggered the IOM’s reevaluation of the 510(k) process. It will provide critical information that will allow patients, physicians and payors to determine the relative value of new devices, which are always more expensive than the ones they replace. In the coming era of cost-controlled medicine, it makes no sense to pay for unproven “improved” devices.

TAGGED:510KFDAmedical 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

New Concussion Sensors, Apps Help Without Solving Key Diagnostic Issues

October 7, 2013
symptoms of serotonin
eHealthGlobal HealthcareHealth careNewsTechnologyWellness

Symptoms of Serotonin Imbalances You Need to Know

September 3, 2017
BusinessMedical InnovationsNews

“Brooklyn Doc Billionaire” Will Unveil Potential Cure For AIDS

March 22, 2012
Health careTechnology

8 Ways Technology Has Changed The Healthcare Industry

August 19, 2019
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?