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Compliance In Focus
Posted by Michael Marotta on Fri, Jan 15, 2016

What to do When New information is Presented?

On the eve of the day we welcomed 2016 the FDA issued a draft guidance regarding notification of the Emerging_Signalspublic on “emerging signals” regarding medical devices that are already used in clinical practice.  The FDA defined an emerging signal as “new information about a medical device” that:

  1. The Agency is monitoring or analyzing
  2. Has the potential to impact patient management decisions and/or alter the known benefit-risk profile of the device
  3. Has not been fully validated or confirmed
  4. For which the Agency does not yet have specific recommendations

The purpose of this guidance was to provide additional clarification regarding the criteria, timeframe, method, and follow-up of communication regarding emerging signals. What is interesting about this guidance is the shift in timeframe for alerting the public.  Previously the FDA has communicated this information to the public following a complete analysis and having either reached a decision or recommendation.  However, this guidance moves up this timeframe as the FDA believes “there is a need to notify the public… even when the information has not been fully analyzed, validated, or confirmed, and for which the Agency does not yet have specific recommendations.” Within the document the FDA acknowledges that there might be “unintended consequences” for public communication prior to complete evaluation of data or without having a specific recommendation.  In an effort to limit these unintended consequences a series of criteria were set forth where the FDA believes that “providing early information to the public outweigh these risks if communicated carefully and thoughtfully.”  These criteria include the following:

  1. The information represents a new, potentially causal association, or a new aspect of a known association (e.g., increased rate or severity of event or reduced benefit), between a medical device and one or more adverse events or clinical outcomes.
  2. The available information is reliable and supported by sufficient strength of evidence.
  3. The information could have important clinical implications for patient management decisions and/or could it significantly alter the known benefit-risk profile of the device.

According to the guidance, when the FDA receives new information regarding a post market medical device an initial assessment should be made within 30 days.  If a public disclosure is not made in response to the information received an internal reassessment should be made upon receipt of subsequent new information.  In the event that public communication is provided, further updates may include:

  1. Providing new information related to the emerging signal collected since the initial public notification.
  2. Update the public that no additional substantive information is available and/or that no known change in the benefit-risk profile of the device has occurred since the last posting.
  3. Notify the public of additional actions being taken or completed by FDA and/or the manufacturer(s).

The guidance recommends a minimum of bi-annual updates until a more formal recommendation is provided or the issue is resolved.

As you would expect this guidance may be looked upon very differently if you had either received the device in question or were the company that manufactured and marketed the device.  A recent article in STAT in regards to the release of the draft guidance suggests that the actions of the FDA could be in response to recent litigation involving safety risks of already approved medical devices.  This article also references MAUDE, a FDA database that houses medical reports submitted to the FDA.  What do you think? 

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Topics: Draft Guidance, FDA, Emerging Signals

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