• 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 » CDRH chief Shuren: 510(k) changes help close the innovation gap

CDRH chief Shuren: 510(k) changes help close the innovation gap

January 19, 2011 By MassDevice staff

FDA logo

Changes to the path by which the vast majority of medical devices hit the U.S. market will help make the U.S. more competitive against European innovators, according to the agency’s top device official.

Dr. Jeffrey Shuren told reporters during a conference call that the changes the Food & Drug Administration plans to make this year to the 510(k) clearance program will help narrow a looming innovation gap between the continents while ensuring the safety of American patients.

"A key piece here is increasing predictability and reducing uncertainty. That is what we’ve heard time and time again," Shuren said.

Asked about a PricewaterhouseCoopers report that the advantage the U.S. medtech industry holds is waning, Shuren said that the U.S. is still the top dog but that uncertainty about the regulatory climate among investors and stakeholders is undermining that status.

CDRH head Dr. Jeffrey Shuren

Shuren

"What we’re proposing today is to address that uncertainty and to keep us a leader in medical innovation for many years to come, while at the same time — and this is critical — assuring that devices are safe and effective," he said. "There are a number of differences between us and the European Union — they have a different standard than we do. Here in the U.S., the device has to be safe and effective. In Europe, a device has to be safe and it has to perform.

"For example, if I have a laser that’s supposed to treat an abnormal heart rhythm — you cut into the heart — in Europe, you have to show that when it cuts the heart, it cuts the heart well. In the U.S., you have to show when it cuts the heart it actually treats atrial fibrillation. It treats the abnormal heart rhythm — that patients get a benefit out of it."

That said, Shuren noted, the U.S. does a better job of protecting patients from potentially harmful devices.

"We also have to remember, ‘Let’s not throw the baby out with the bathwater,’" Shuren said. "Here in the U.S., devices are safe and effective, but in many cases — and we have a number of examples — devices that came on the market in Europe, when they had to show data here for the U.S. we found they have safety concerns, where they didn’t work and they came off the market in Europe thereafter.

"I’ll leave this with a quote regarding one particular technology that was recently removed from the [EU] market. It was a breast implant that never made it here [in the U.S.]. This is from Nigel Mercer, a former president of the British Assn. of Aesthetic and Plastic Surgeons. He recently stated that, ‘Under the EU system, the public are being used as guinea pigs.’ We don’t use our people as guinea pigs in the U.S."

Filed Under: Business/Financial News, Food & Drug Administration (FDA), News Well Tagged With: Gift Bans

More recent news

  • EBR Systems raises $36.1M for leadless pacing tech
  • The biggest cardiovascular tech news out of EuroPCR 2025
  • CardiaWave has positive 12-month Valvosoft results
  • Elixir Medical reports sustained durability with bioadaptor compared to Medtronic stent
  • Medtronic has new Cardiovascular, CST leaders after longtime exec departs

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