Regulatory Open Forum

 View Only

  • 1.  Adverse events, etc.

    This message was posted by a user wishing to remain anonymous
    Posted 12-Feb-2024 09:02
    This message was posted by a user wishing to remain anonymous

    Hello RAPS,

    Could somebody, please share a clear differentiation between adverse event, FSCA, serious incident, and recall?

    Thank you!



  • 2.  RE: Adverse events, etc.

    Posted 12-Feb-2024 10:33

    Hi Anon,

    could you share for which jurisdiction you would like the respective clarification?

    Best regards, Christoph



    ------------------------------
    Christoph Kiesselbach
    Schrack & Partner
    Reutlingen
    Germany
    ------------------------------

    Original Message


  • 3.  RE: Adverse events, etc.

    Posted 12-Feb-2024 12:32

    As Christoph implies, we need to know the applicable jurisdiction(s) because different jurisdictions have different definitions for these terms (and some of these terms aren't recognized at all in certain jurisdictions).  We also need confirmation that you are asking about medical devices rather than pharmaceuticals, biologics, cosmetics, etc.  In the meantime, here are some general principles for the medical device space:

    • "Adverse Event" is a most general term, not often specifically defined, and where some but not all adverse events are "incidents", "serious incidents", "reportable events", etc.  The U.S. FDA for example has an official and broad definition for "adverse event" whereby not all "adverse events" are reportable.  But FDA doesn't use the terms "incident" or "serious incident" in an official sense.  In contrast, Europe's MDR uses and defines the term "adverse event", but only in relation to clinical investigations.
    • "Incident" and "Serious Incident" are particular types of reportable events and will have jurisdiction-specific definitions.
    • FSCA and recall are types of corrections (e.g., see ISO / EN ISO 9000 definition) that may be needed in response to an adverse event.  Again, FSCA and recall are jurisdiction-specific. For example, for Europe's MDR, an FSCA may or may not be a recall, and vice versa.  In the U.S., the FDA doesn't officially recognize the term "FSCA", instead using terms like "recall" or "market withdrawal" where FDA's definitions for these terms are not the same as Europe's (or other jurisdictions') same or similar terms.


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

    Original Message


  • 4.  RE: Adverse events, etc.

    Posted 13-Feb-2024 13:12

    Be sure to also remember not to overextend, underextend or otherwise morph these terms into meanings or requirements that are not intended.  Such an approach can cause costly compliance campaigns such as underreaction or overreaction.

    For example, in the FDA jurisdiction, there are class I, II, and III recalls.  FDA doesn't generally require class III recalls to be reported to FDA. Thus, reporting a class III recall to the FDA (or otherwise having FDA declare the class III recall) can be a costly strategy.  Instead, firms are allowed to declare and manage class III recalls independently.  Many firms find such autonomy to be a preferred approach rather than voluntarily causing official FDA involvement when not required.

    And regarding class I and II recalls that must be reported to FDA, it is in your best interest to proactively declare which class you believe applies rather than forfeiting your due process rights and waiting as a sitting duck for FDA.  It is true that FDA has the final say and authority, but we are welcomed to lay the groundwork for the final recall classification.  The key to that is mimicking FDA's own HHE approach and then submitting it in the appropriate section of your report to FDA.

    Another important point is that not all "adverse events" (as FDA defines it) are reportable to the FDA.  Thus, submitting MDR reports for all adverse events is certainly not the intent of FDA's MDR reporting regulations, and FDA has officially told us this.  Therefore, it is not advisable to submit MDR reports to FDA for all "adverse events" as defined by FDA.  Again, many firms would consider it undesirable to have such unnecessary official and public involvement of FDA.



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

    Original Message


  • 5.  RE: Adverse events, etc.

    Posted 13-Feb-2024 10:03

    This is an area with a lot of generic terms and a lot of regulatory region defined terms. Often they are used interchangeably, so a little caution is required.

    An adverse event is usually a generic term meaning that a patient or user has been harmed or there was a near miss.

    In the US, adverse events are reported as medical device reports, MDRs, under Part 803.

    In the EU-MDR, adverse events relate to clinical investigations only. For other products the term is incident. Incidents are reported under either Art. 87 or Art. 88.

    Serious incident is one of the two categories of incidents in the EU. Serious incidents are reported under Art. 87 which has a further classification that determines the time to report. Not serious incidents are collected and analyzed for a statistically significant increase. If there is one, report under Art. 88.

    An FSCA, Field Safety Corrective Action, is an EU-MDR term meaning that the manufacturer notifies the regulator of a need to change a device already shipped because of a safety problem. FSCA are reported under Art. 87 and Art. 89. An FSCA always has one or more FSN, Field Safety Notice, which informs the user of the problem. FSN must meet the language requirements, so a given FSCA could have multiple FSNs.

    A recall can be a generic term meaning that the manufacturer needs to change something about a device already shipped.

    In the US, only the FDA can declare something is a recall. They classify them as either voluntary on involuntary. Involuntary recalls are rare, as remember there have been only three.

    Most recalls are voluntary and start with a Part 806 Corrections & Removals Report. The FDA determines whether the C&R report is a recall, assigns a recall class, determines if it is a correction, a removal, or both..

    In the EU-MDR a recall means any measure aimed at achieving the return of a

    device that has already been made available to the end user. A withdrawal means any measure aimed at preventing a device in the supply chain from being further made available on the market. See Art. 10(12).



    ------------------------------
    Dan O'Leary CQA, CQE
    Swanzey NH
    United States
    ------------------------------

    Original Message


Related Content