Regulatory Open Forum

 View Only
  • 1.  Class III recall reporting

    This message was posted by a user wishing to remain anonymous
    Posted 22-Mar-2024 09:07
    This message was posted by a user wishing to remain anonymous


    I am confused about the regulations on voluntary or firm-initiated recalls. If our company will perform a field correction which meets the definition of a class 3 recall, because there is no risk to health associated with the devices that are corrected, do we need to report it to the FDA? According to 21CFR806 it seems we do not need to report to the FDA because the correction is not intended to reduce risk to health or to remedy a violation which may present a risk to health. However according to 21CFR7.46 we need to notify the FDA anyway.

    I hope the Forum can shed a little light on this. I'm sure we're not the first company facing this situation.

  • 2.  RE: Class III recall reporting

    Posted 22-Mar-2024 09:18

    The manufacturer does not determine the class of a recall, CDRH does. As a manufacturer, follow Part 806 to make the reportability decision. Do not try to classify the recall to make the decision.

    If you report, then CDRH will follow Part 7 to classify the recall.

    Part 806 applies to the manufacturer, not to CDRH.

    Part 7 applies to CDRH, not to the manufacturer.

    Dan O'Leary CQA, CQE
    Swanzey NH
    United States

  • 3.  RE: Class III recall reporting

    Posted 22-Mar-2024 10:37

    Hello Anon

    If you haven't already reviewed this guidance, you may find it helpful:

    If it's not reportable, then you just keep all the records, in case an FDA reviewer requests them later. It will also help to keep a document showing your rationale for why it's reportable or not reportable.

    Anne LeBlanc
    United States

  • 4.  RE: Class III recall reporting

    Posted 22-Mar-2024 12:19

    Collectively, Part 7 and 806 in total only involve a firm's recall-related correspondence with FDA for two scenarios:

    1. Mandatory Part 806 reports for those situations that track as Part 7 Class I and Class II recalls; and
    2. Voluntary (as in, not required) Part 7 notification by the firm to FDA for Class III recalls (and other recalls too if desired by the firm).

    This summary is officially established by Parts 7 and 806 as interpreted by FDA when it promulgated these regulations via their formative preambles. I like remembering FDA's prior statement that its preamble interpretations can be used in court to demonstrate FDA's interpretation of its regulations.  In prior Forum posts such as here and here and others, I've extensively elucidated these official FDA positions along with their formative regulatory work-up / history.

    As elaborated in my prior posts, Part 7 plainly states that Part 7 is for both FDA and industry. There are regulatory and practical reasons for this. FDA intends for the overwhelming majority of recalls to be initiated by firms rather than FDA. And since 7.46 doesn't require immediate (nor any other) notification to FDA for class III recalls, it shows that firms may (and in fact, must) classify, initiate, and execute such recalls independent of FDA.  Specifically, 7.46 states that firms are "requested" to notify FDA and deliberately uses the term "requested" rather than "required" because of FDA's intentional removal of the original proposed provision for such requirement.

    Ultimately, it is not possible for a firm to properly design and execute recall communications, depth, extent, follow-up, effectiveness-checks, corrective action, etc., without taking a risk-based consideration of the issue.  These recall features must be commensurate with the risk.  Specifically, firms need to handle these commensurate with the way FDA would handle them.  This means proactively and methodically applying the Class I-II-III recall classification scheme.  A firm's deviation from that approach (such as if a firm decides not to classify its recall) can have costly consequences for all stakeholders.

    A final note about 7.46's voluntary notification clause: Be sure you consult with your firm's management with executive responsibility (MER) so that you can be aligned with MER's preferences and sensitivities about voluntarily involving FDA in your recall activities when such FDA involvement is not otherwise required.  Many firms prefer to involve FDA into their affairs only when required by law or regulation to do so.

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