• Skip to primary navigation
  • Skip to main content
  • Skip to primary sidebar
  • Skip to footer
  • Advertise
  • Subscribe

MassDevice

The Medical Device Business Journal — Medical Device News & Articles | MassDevice

  • Latest News
  • Technologies
    • Artificial Intelligence (AI)
    • Cardiovascular
    • Orthopedics
    • Neurological
    • Diabetes
    • Surgical Robotics
  • Business & Finance
    • Wall Street Beat
    • Earnings Reports
    • Funding Roundup
    • Mergers & Acquisitions
    • Initial Public Offering (IPO)
    • Legal News
    • Personnel Moves
    • Medtech 100 Stock Index
  • Regulatory & Compliance
    • Food & Drug Administration (FDA)
    • Recalls
    • 510(k)
    • Pre-Market Approval (PMA)
    • MDSAP
    • Clinical Trials
  • Special Content
    • Special Reports
    • In-Depth Coverage
    • DeviceTalks
  • Podcasts
    • MassDevice Fast Five
    • DeviceTalks Weekly
    • OEM Talks
      • AbbottTalks
      • Boston ScientificTalks
      • DeviceTalks AI
      • IntuitiveTalks
      • MedtechWOMEN Talks
      • MedtronicTalks
      • Neuro Innovation Talks
      • Ortho Innovation Talks
      • Structural Heart Talks
      • StrykerTalks
  • Resources
    • About MassDevice
    • DeviceTalks
    • Newsletter Signup
    • Leadership in Medtech
    • Manufacturers & Suppliers Search
    • MedTech100 Index
    • Videos
    • Webinars
    • Whitepapers
    • Voices
Home » Hauser’s FDA Rx: The FDA needs an NTSB

Hauser’s FDA Rx: The FDA needs an NTSB

March 11, 2013 By Arezu Sarvestani

Dr. Robert Hauser

Dr. Robert Hauser hopes to push a major change at the FDA, looking to shift the monitoring of medical devices and drugs that are already on the market from the FDA to an independent entity.

Hauser, a long-time patient safety advocate and vocal FDA critic, is aiming to sell Capitol Hill on a new structure for the U.S. healthcare regulation system akin to how the nation deals with transportation safety, he told MassDevice.com in an exclusive interview.

"We need an independent organization to look at major adverse events associated with drugs and devices, separate from the FDA and which has no regulatory authority, whose only job is to investigate and then report their findings," Hauser told us today during the American College of Cardiology conference in San Francisco. "I’m interested in making a safer device or drug for a patient. I’m going to recruit a couple people and go to Congress."

The concept is still in its infancy – the 1st time Hauser mentioned it to anyone was during a panel at the ACC conference yesterday, he said.

Hauser, a veteran of the Minneapolis Heart Institute who’s well-known among cardiologists, likens his healthcare proposal to the U.S. regulatory structure for airlines, in which the FAA handles most of the work while the entirely independent National Transportation Safety Board monitors and investigates accidents and is solely responsible to Congress.

Establishing a separate agency with the authority to handle healthcare problems such as medical device recalls would help relieve a fundamental conflict of interest with in the FDA, according to Hauser.

"The FDA is being asked to approve devices and then to be responsible for monitoring performance for devices and drugs," he said. "Right away, you have a conflict because the group that approved the drug is going to question the group that is now criticizing the drug.

"They’re all in 1 agency, and I doubt that the lines of authority, responsibility, accountability are clear. How objective can a group be, inside the agency, when it’s discussing, potentially, the performance of another group inside the agency?"

The proposed bureau, which Hauser said could be called the "National Drug & Device Safety Board," would have engineers, scientists, statisticians and administrators, and a board to report its findings to Congress.

The group would monitor healthcare products after they’re given the green light by the FDA, participating in post-market studies and watching registries from around the world. Hauser’s vision is that the data gathered would be completely transparent, fully open to the public. That could confer an added benefit for medical device companies and drug makers, giving them access to a comprehensive database of adverse events to help them avoid similar problems in newer products, he noted.

There are obstacles to be overcome. For example, information on issues with particular materials in medical devices, isn’t shared with other device makers due to its proprietary nature, he told us. And the FDA under the Obama administration has not welcomed recommendations for change. When the Institute of Medicine recommended in 2011 that the federal watchdog agency completely scrub its 510(k) fast-track review of medical devices, the FDA quickly responded that it was "not bound to adopt IOM recommendations."

Hauser is acutely aware of the hurdles he’ll face in proposing a massive change to the regulatory system, but he’s pressing onward anyway.

"Idealistic? Well, yeah, but it’s kind of practical, too – why would we want people to repeat mistakes that have already been made?" he told us. "There’s 1 chance in 100, but it’s worth taking the chance. It’s worth the effort, because maybe in the conversation something will happen that’ll change things."

Filed Under: Food & Drug Administration (FDA), Healthcare Reform, News Well Tagged With: American College of Cardiology Conference (ACC), Conference coverage

More recent news

  • Imperative Care, Proximie partner to develop surgical robot to treat stroke
  • Carlsmed launches IPO roadshow
  • Varian introduces IntelliBlate for image-guided cancer therapy in Europe
  • Henry Schein CEO Stanley M. Bergman to retire
  • Medtronic wins CE mark for LigaSure sealing tech for Hugo surgical robot

Primary Sidebar

“md
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest med device regulatory, business and technology news.

DeviceTalks Weekly

See More >

MEDTECH 100 Stock INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
MDO ad

Footer

MASSDEVICE MEDICAL NETWORK

DeviceTalks
Drug Delivery Business News
Medical Design & Outsourcing
Medical Tubing + Extrusion
Drug Discovery & Development
Pharmaceutical Processing World
MedTech 100 Index
R&D World
Medical Design Sourcing

DeviceTalks Webinars, Podcasts, & Discussions

Attend our Monthly Webinars
Listen to our Weekly Podcasts
Join our DeviceTalks Tuesdays Discussion

MASSDEVICE

Subscribe to MassDevice E-Newsletter
Advertise with us
About
Contact us

Copyright © 2025 · WTWH Media LLC and its licensors. All rights reserved.
The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media.

Privacy Policy