Skip to content
Eisner Safety Consultants

Eisner Safety Consultants

Just another WordPress site

Menu

  • HOME
  • ABOUT US
    • ESC EXPERTS & ASSOCIATES
    • ESC Partners
    • ESC Affiliates
  • BLOG
  • SPECIALIZED SERVICES
  • SCHEDULE MEETING
  • RESOURCES
    • CURRENT IEC 60601/80601 STANDARDS
    • DRAFT IEC 60601/80601 STANDARDS
    • ARCHIVES
      • ARCHIVE PUBLICATIONS
      • Isolation/Insulation Diagrams
  • CONTACT

FDA 510(k) changes announcement Jan 19 2011 from MassDevice

MassDevice online article 1/19/2011 – The FDA 510(k) changes are to be announced today, Jan 19 2011. http://ht.ly/3Gz2O

FDA 510(k) changes announcement Jan 19 2011 from MassDevice
leoeisner January 19, 2011 Uncategorized
  • ← Leo Eisner Presenting @ DesignMed on IEC60601-1-11 Home Healthcare
  • FDA Updates 515 Prog. Initiative Webpage (reclassified preAmend Class III 510(k)s) →

Recent Posts

  • IEC 60601 Updates: What MedTech Need to Know for 2025 and Beyond Podcast

    IEC 60601 Updates: What MedTech Need to Know for 2025 and Beyond Podcast

    December 12, 2024
  • The most valuable asset we each bring to the table is⁉️ Our unique experiences and innovation

    The most valuable asset we each bring to the table is⁉️ Our unique experiences and innovation

    September 30, 2024
  • Time and Regulators Wait for No One – Free Presentation

    Time and Regulators Wait for No One – Free Presentation

    September 28, 2024
  • What Standards Apply to My Device? Podcast #383

    What Standards Apply to My Device? Podcast #383

    September 25, 2024
  • Join Leo Eisner In The Next Let’s Talk Risk Episode

    Join Leo Eisner In The Next Let’s Talk Risk Episode

    August 30, 2024
  • Free Presentation in London Oct 7 On IEC 60601-1, 4th Ed. and Meet with Leo Eisner in London

    Free Presentation in London Oct 7 On IEC 60601-1, 4th Ed. and Meet with Leo Eisner in London

    August 29, 2024

Categories – Drop Down

Categories – Hot Topics

510(k) 60601 series 60601-1 60601-1 3rd ed. A1 AAMI AAMI ES60601-1 AAMI ES60601-1/C1 Active Implantable Medical Devices Directive AIMDD Amendment 1 ANSI/AAMI ES60601-1 CDRH CENELEC Collateral Standard EN60601 EN60601-1 ESCNews EU European Commission FDA FDA Guidance Health Canada Home Healthcare Environments Home Use Home Use Environment Home Use Med Dvcs IEC IEC 60601-1 IEC60601-1 IEC60601-1 3rd ed. IEC60601-1-11 ISO 14971 IVD IVDD MDD MDD Amendment Medical Medical Device Medical Device Directive Medical Device Industry Medical Device Regulatory Medical Devices Notified Body Risk Management

Newsletter Sign-up

Subscribe

* indicates required

View our previous newsletters.

Powered by MailChimp

Eisner Safety Consultants will use the information you provide on this form to be in touch with you and to provide updates and marketing. Please let us know you would like to hear from us by e-mail:

You can change your mind at any time by clicking the unsubscribe link in the footer of any email you receive from us, or by contacting us at . We will treat your information with respect. For more information about our privacy practices please visit our website. By clicking below, you agree that we may process your information in accordance with these terms.

We use Mailchimp as our marketing platform. By clicking below to subscribe, you acknowledge that your information will be transferred to Mailchimp for processing. Learn more about Mailchimp's privacy practices here.

Recent Industry News

  • IEC 60601 Updates: What MedTech Need to Know for 2025 and Beyond Podcast

    IEC 60601 Updates: What MedTech Need to Know for 2025 and Beyond Podcast

    December 12, 2024
  • The most valuable asset we each bring to the table is⁉️ Our unique experiences and innovation

    The most valuable asset we each bring to the table is⁉️ Our unique experiences and innovation

    September 30, 2024
  • Time and Regulators Wait for No One – Free Presentation

    Time and Regulators Wait for No One – Free Presentation

    September 28, 2024
  • What Standards Apply to My Device? Podcast #383

    What Standards Apply to My Device? Podcast #383

    September 25, 2024
  • Join Leo Eisner In The Next Let’s Talk Risk Episode

    Join Leo Eisner In The Next Let’s Talk Risk Episode

    August 30, 2024

Links and Resources

  • Our Profile
  • Our Associates
  • Our Specialized Service
  • Archive Publications
  • Current IEC 60601-1 Standards
  • Draft IEC 60601-1 Based Standards
  • Blog (Industry News)
  • Resources

Contact Us

  • Address
  • 2866 NW Fairfax Terrace
  • Portland, OR 97210
  • Email: Leo at EisnerSafety dot com
  • Website: Eisner at EisnerSafety dot com
Copyright © 1999 - 2024 Eisner Safety Consultants. Designed by Tania Avanzi, ClubWeb. All rights reserved. Theme base Spacious by ThemeGrill. Powered by WordPress.
  • Industry News