Regulatory Open Forum

 View Only
  • 1.  Advisory notice

    This message was posted by a user wishing to remain anonymous
    Posted 17-Nov-2023 15:11
    This message was posted by a user wishing to remain anonymous

    Good morning,

    Is there any rule about who should write advisory notices (advice/supplementary information on the use of a medical device);  is it QA, RA, or another department's responsibility? And is there any time frame to send it to the customer?

    Thank you for your thoughts.

  • 2.  RE: Advisory notice

    Posted 17-Nov-2023 16:18

    There is no rule about who should write an advisory notice. In practice, think of it as an extension of the IFU, so follow the company's practice for preparation and review.

    In the US, an advisory notice falls under Part 806 Corrections and Removals. That regulation has time frames and record keeping requirements.

    If an advisory notice is important enough to write, then it should go out quickly. I recommend 5 working days from realizing the issue.

    Dan O'Leary CQA, CQE
    Swanzey NH
    United States

  • 3.  RE: Advisory notice

    Posted 19-Nov-2023 05:29

    Hello Anon,

    The author of an Advisory Notice should not necessarily just be one person.  While one person may write the Advisory Notice, there would probably be different people, functions, and responsibilities involved in components or parts.  The person(s) writing and responsible for acceptance should be those knowledgeable with the situation, product, and understanding of dissemination of information to the public.  Typically in my experience it would be managed by Regulatory Affairs as a regulatory or compliance activity, though it could be Quality or another department.

    The timeframe should be defined by the recall management plan which can depend on a few different factors such as the health hazard assessment, means of communication, depth of the recall, etc.  Though indeed the timing should be and probably needs to be short depending on the situation.  The recall/field notice process and timing should be detail in the recall management planning.

    Richard Vincins ASQ-CQA, MTOPRA, RAC
    Vice President Global Regulatory Affairs

  • 4.  RE: Advisory notice

    Posted 20-Nov-2023 13:02

    You are wise to be careful regarding advisory notices, as their management shouldn't be oversimplified.

    If an advisory notice is being issued in association with a safety-related recall, field safety corrective action, etc., (depending on the affected jurisdiction) then the general rule is that a qualified Regulatory professional needs to be the author, yet with due consideration of input from other stakeholders.  This is because there are critical regulatory requirements governing the content of such advisory notices.  If the advisory notice is not first drafted by such a Regulatory person, then it will at best be inefficient, and worse, could be violative.

    For example, one way the U.S. FDA governs the content of a recall communication is via its recall communication regulation in Part 7 (Enforcement Policy) specifically asserting that recall communications should not contain irrelevant qualifications, promotional materials, or any other statement that may detract from the message.  FDA put this in its recall communication regulation because of the longstanding concern that authors from the sales/marketing function might objectionably interject sales and marketing efforts into the recall communication.

    Europe's Union has a similar sentiment in its field safety notice regulation [e.g., Regulation 2017/745 Article 89(8)] where it requires that such an advisory notice shall explain, in a clear manner, without understating the level of risk, the reason for the notice.  Again, sales and marketing overtures are a key concern when assuring that the risk isn't understated; thus, further need for qualified regulatory authorship.

    Note also for the U.S. jurisdiction that, although a copy of the advisory notice is required to be included in a Part 806 report or in the firm's internal records of non-reportable corrections or removals, it remains true that the contents and timelines for an advisory notice aren't covered by Part 806. For example, Part 806 provides no timelines whatsoever for issuance of an advisory notice (nor does it intended to, as the fundamental purpose of Part 806 is about notifying FDA about certain types of corrections or removals; it is not about issuance of advisory notices to recipients).  Accordingly, be sure not to confuse or misappropriate Part 806 regarding FDA's separate requirements for issuance of U.S. advisory notices.  I expect FDA to clarify this when it finalizes its imprecise language drafted into the proposed Part 820 changes.  Rather than Part 806, look instead to FDA's Part 7 enforcement policy which prescribes that the advisory notice needs to be issued "promptly".

    For Europe's Union, advisory notices that are field safety notices shall be issued "without delay".  Yet there are sensible boundaries for this, such as to first provide a draft of the field safety notice to the evaluating competent authority so it can make comments except in cases of urgency or certain other scenarios [e.g., Article 89(9) scenarios].

    Rather that prescribing a set timeline for such jurisdictions that don't definitely state a particular timeline for issuance of advisory notices, I instead recommend that your procedure instead require that it be done with good faith urgency regarding the level or risk.  Otherwise, you will inevitably fall out of compliance regarding arbitrary timelines like 5 days.

    For example for Canada, in its recall "guidance" that is enforced by Health Canada as if it is regulation (e.g., I've had clients receive official citations from Health Canada for not having procedures that match the parameters in the guidance), Canada prescribes advisory notice timelines that are anywhere from 1-7 days depending on the level of risk involved.

    Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
    Principal Consultant
    Ridgway, CO
    United States
    © Copyright 2023 by ComplianceAcuity, Inc. All rights reserved.