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  • 1.  Class 1 medical device consulting question

    This message was posted by a user wishing to remain anonymous
    Posted 29-Sep-2020 08:40
    This message was posted by a user wishing to remain anonymous

    Hi, I got a class 1 medical device(glove) 510k application consulting from a company in Singapore for US submission. I know how to submit a 510k submission for class 1 but this is my first time as consultant. Please help me as how to proceed. What questions should I ask the company? As a freelance consultant what will I need?


  • 2.  RE: Class 1 medical device consulting question

    Posted 29-Sep-2020 12:55
    I am not following what being a consultant has to do with this, but the answer is straightforward, so here goes. Hope it helps.

    Figure out the Product code and Regulation number. Most Class I are exempt from 510(k) reqs, some are exempt from GMP too. Follow the link to get FDA required info for the company device https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/315.cfm. Make sure the company registers their establishment, confirm they have complaint handling in place and have a validated document repository for their records. If the company product is exempt from both 510(k) and GMP, they will write a LTF. Make sure the letter to file is robust and not check-the-box, in case it needs to be leveraged in the future. 

    All of this info and more is easily found on FDA website.

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    Adam Atherton
    Farragut TN
    United States
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    Original Message


  • 3.  RE: Class 1 medical device consulting question

    Posted 30-Sep-2020 07:42
    Gloves are Class 1, but not exempt from premarket notification.  I suggest reviewing and choosing a predicate device to identify the information that has been needed for their clearance listed in the 510(k) Summary, then ensure you have all of these addressed.

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    Lee Leichter RAC
    President
    Fort Myers FL
    United States
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    Original Message


  • 4.  RE: Class 1 medical device consulting question

    Posted 01-Oct-2020 01:51
    Hi Anon,

    My million dollar question is "Are you really ready to be a consultant?".

    Many times you will have to take strong and quick decisions, without having the time to consult others.
    It needs courage and experience to know that one mistake or one oversight can cause thousands or possibly millions or dollars to a company.
    Because at the end of the day they trust the consultant with the process.

    Please reflect on that.

    ------------------------------
    Spyros Drivelos
    Medical Devices Expert, RAC
    Agia Paraskevi, Athens
    Greece
    ------------------------------

    Original Message


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