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  • 1.  510K Amendment during Substantive Review process

    Posted 11-Jun-2018 16:45
    Hello All,

    We were asked by FDA to submit an amendment for a pending 510k because of change in primary contact.
    I am not sure how to do that? Can someone who has similar experienced point out the right way or guidance or anything that could help me please?

    Thanks

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    Jinali Bhavsar RAC
    Regulatory Affairs Specialist
    San Jose CA
    United States
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  • 2.  RE: 510K Amendment during Substantive Review process

    Posted 12-Jun-2018 05:25
    Jinali,

    You just need to send a formal letter on company letterhead indicating that the primary contact has changed.  Normally I had seen FDA asking for this type of letter only for external parties that were working with the sponsor of the 510(k) but more and more I see them requesting this for even changes within the company itself.  Send the letter to the address that you made the original submission making sure to reference the 510(k) number clearly in the letter.  If you are corresponding to the reviewer via email, they may accept that only through email; you should inquire as they may accept the "amendment" letter with a cc: to the email address K18####@docs.fda.gov.  Otherwise send in a hard-copy letter to the submission address.

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    Richard Vincins RAC
    Vice President Regulatory Affairs
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    Original Message


  • 3.  RE: 510K Amendment during Substantive Review process

    Posted 12-Jun-2018 07:20
    Jinali

    I would think that the request would reference the procedure and regulations that apply to this.

    In the event that they do not, I would treat it as a response to an Additional Information request and submit a response as Kxxxxxx/S00x with a cover letter explaining the reason for the submission and an updated Form 3514.

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    Jean Bigoney PhD, RAC
    Managing Member
    Murphy NC
    United States
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    Original Message


  • 4.  RE: 510K Amendment during Substantive Review process

    Posted 13-Jun-2018 12:04
    Jinali,
    Richard's response is correct. You should fill out the CDRH Cover Sheet Form 3514. The submission # will be KXXXXXX/A001. Then just draft a cover letter ​on company letterhead that designates the new contact. I agree with Richard, "If you are corresponding to the reviewer via email, they may accept that only through email; you should inquire as they may accept the "amendment" letter with a cc: to the email address K18####@docs.fda.gov." If not, you should be able to submit only the ecopy, but I would ask the reviewer. 

    Just so you know, this doesn't stop the review clock and the information will just be added to your official file.

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    Michael Nilo
    Network Regulatory Partners
    Portland OR
    United States
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    Original Message


  • 5.  RE: 510K Amendment during Substantive Review process

    Posted 14-Jun-2018 06:12
    I actually did something similar two months ago. I contacted the reviewer first and asked if I could send an update to the Labelling or did I have to send it as an amendment.  It was accepted in an email since the review of the 510(k) wasn't completed at that time.

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    Colleen Powell
    Director of Regulatory Affairs
    Gloucestershire
    United Kingdom
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    Original Message


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