Regulatory Open Forum

 View Only
  • 1.  Labeling (warnings and precautions)

    This message was posted by a user wishing to remain anonymous
    Posted 7 days ago
    This message was posted by a user wishing to remain anonymous

    Hello Experts,

    I come from the Pharma side regulator and currently working on a new project; a class III IVD diagnostic for cancer. In my view, for our patient IFU the risk of erroneous results (i.e. false positive/negative) should be included in the warnings and precautions section. As of right now it's listed on its own page in the IFU under a section called "results" which go into what a positive mean, etc... and the test could give you false positive/negatives) .... Ultimately we are addressing the risk/harm factor there but in the drug world it has to be listed under "warnings and precautions", there are very strict labeling guidelines. I'm having a hard time taking off my drug hat here therefore wanted to get different opinions if you think FDA will accept this?

    Thank you 

  • 2.  RE: Labeling (warnings and precautions)

    Posted 7 days ago
    Hello Anon

    Normally you'll see a summary of general warnings and precautions at the beginning of the IFU, and specific warnings and cautions as applicable in each section. If you're thinking of trying an unusual layout, it could be especially important to cover that in the usability studies, to find out if the users are understanding what they need to understand.

    Here's a helpful guidance with FDA perspective:

    Anne LeBlanc
    United States

  • 3.  RE: Labeling (warnings and precautions)

    Posted 6 days ago
    Hello Anon,

    Warnings and precautions in medical device labelling should be linked to your risk management process, specifically residual risks.  This is a complicated and fairly mis-understood area on how risk control applies, information provided to the user, and what are considered residual risks.  Depending on definitions and how applied, cautions also would not be residual risks, but only information for the user - such as something which came out of usability studies.  Then it goes even over-board in the European Union where Notified Body reviewers/auditors want to see every risk listed in the Instructions for Use (labelling).  Another approach to use also is state of the art to see what similar IVD devices or competitive devices are listing in their labelling, but use care because that may also not always be correct.  In the medical device world, there is no prescriptive requirements for warnings, precautions, cautions such as in the pharmaceutical world because there is such a variety of products to consider and establishing a standardised warnings and/or cautions list would be a monumental task.  Just make sure to use the risk management process for developing, linking, and disclosing risks associated with the device (and IVD devices have other considerations since there is no direct patient contact).

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

  • 4.  RE: Labeling (warnings and precautions)

    Posted 6 days ago
    Hi Anon

    This is an interesting example, and would apply (not exclusively) to most diagnostic and measurement devices. I think this example sits in the crossover between:
    1. statement of relevant performance specifications,
    2. warnings and precautions (as a means to communicate information for safety to the user with the aim of reducing/controlling risk)
    3. disclosure of residual risk that provides transparency about the 'risks' being accepted when using this device.

    My interpretation of this example would then look like this:
    1. e.g. statement of sensitivity, specificity etc.
    2. e.g. directions for use, precautions to be taken and warnings about steps that the user can take to ensure that the device performs as intended
    3. e.g. clear identification of the likelihood of a false positive and false negative

    I would also suggest you review the requirements of ISO 20417 and also the guidance in ISO TR 24971 Annexes about information for safety.

    Edward Ball
    Manager, Intelligence & Innovation
    United Kingdom