• 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 » FDA launches cybersecurity initiative

FDA launches cybersecurity initiative

October 1, 2014 By Alex Soule

FDA launches cybersecurity initiative

The FDA is asking medical device manufacturers to submit documentation about cybersecurity controls they have in place to mitigate the threat of hackers accessing devices, including ongoing software patches and updates to operating systems.

The FDA issued the recommendations in a document to be released in full Thursday titled "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices," after having released a draft version last June. On Tuesday, the agency stated it found no indication that specific devices or systems have been purposely targeted by hackers, but remains concerned about device-related cybersecurity vulnerabilities.

"There is no such thing as a threat-proof medical device," Suzanne Schwartz, director of emergency preparedness/operations and medical countermeasures at the FDA’s Center for Devices and Radiological Health, said in prepared remarks. "It is important for medical device manufacturers to remain vigilant about cybersecurity and to appropriately protect patients from those risks." 

The FDA scheduled a public workshop Oct. 21-22 to discuss how government, medical device developers, hospitals, cybersecurity professionals, and other stakeholders can collaborate to improve the cybersecurity of medical devices and protect the public health. Last year the watchdog agency said it would put together a “cybersecurity laboratory” to test new medical products.

The FDA’s concerns about cybersecurity vulnerabilities include:

  • Malware infections on network-connected medical devices or computers, smartphones, and tablets used to access patient data;
  • Unsecured or uncontrolled distribution of passwords;
  • Failure to provide timely security software updates and patches to medical devices and networks;
  • Security vulnerabilities in off-the-shelf software designed to prevent unauthorized access to the device or network.

Filed Under: Food & Drug Administration (FDA), News Well, Regulatory/Compliance Tagged With: Cybersecurity

More recent news

  • NICE recommends Boston Scientific Farapulse pulsed field ablation tech
  • SS Innovations completes first robotic telesurgery for weight loss
  • Johnson & Johnson MedTech adds new CMO for its Electrophysiology business
  • Abbott earns Medicare win for TriClip TEER system
  • Judge says Johnson & Johnson Ethicon owes $76.6M to ChemImage after failed partnership

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