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  • 1.  Class I device

    Posted 03-Nov-2022 21:48
    Hi All, 

    Not very familiar with US FDA Class I devices. 

    - Some class I device require pre-market notification? What does that include? Is it similar to a 510(k)submission or is it just submitting some performance testing for the device? Any guidance.

    - Class I exempt device, only needs to be listed in the  FDA's website (FURLS)? This does not require any submission to the FDA?

    Thank you

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    Suraj Maharjan
    Sr. Regulatory Affairs Specialist
    Windham NH
    United States
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  • 2.  RE: Class I device

    Posted 04-Nov-2022 08:44
    Edited by Kevin Randall 04-Nov-2022 08:45
    "Premarket notification" = 510(k) Submission.  Indeed, 21 CFR Part 807 Subpart E (Premarket Notification Procedures) is the implementing regulation for Section 510(k) of the FD&C Act.

    510(k)-exempt devices do not require a 510(k) (a.k.a. Premarket Notification), but require establishment registration, device listing, GMP compliance (unless also GMP-exempt), and several other FDA regulations (e.g., Parts 801, 803, 806, 830, etc.)

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    Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
    Principal Consultant
    Ridgway, CO
    United States
    © Copyright 2022 by ComplianceAcuity, Inc. All rights reserved.
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    Original Message


  • 3.  RE: Class I device

    Posted 04-Nov-2022 10:01

    Class I devices are the lowest risk class. Most do not require a pre-market notification which is all known as a 510(k). However, there are exceptions. You need to classify the device using the FDA website, determine the Product Code, and look at the information there to see if the device requires a pre-market notification.

    The word exempt needs a qualifier. Some Class I devices are exempt from pre-market notification, some are exempt from design controls, and some are exempt from QSR.

    A device manufacturer must register and list. The includes all devices regardless of class, exemptions, etc.



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    Dan O'Leary CQA, CQE
    Swanzey NH
    United States
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    Original Message


  • 4.  RE: Class I device

    Posted 06-Nov-2022 14:10
    FDA, and especially CDRH, have award-winning webpages to introduce medical device regulations.

    Try Device Advice: Comprehensive Regulatory Assistance > Overview of Device Regulation > classify your medical device whenever you need help. Good luck.

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    Andrea Chamblee Esq., RAC, FRAPS
    Senior Counsel, Wilson Sonsini

    This information and views expressed are provided in my capacity as an FDA and compliance professor at Johns Hopkins and George Washington universities, and as a RAPS Fellow.
    This is not intended as legal advice. Consult a lawyer for your specific matter.

    Maryland
    United States
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    Original Message


  • 5.  RE: Class I device

    Posted 07-Nov-2022 08:35
    Thank you! :-)

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    Deborah Collins
    San Carlos CA
    United States
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    Original Message


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