FDA Medical Device Industry Coalition (FMDIC)

FDA Medical Device Industry Coalition (FMDIC)

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David

FDA Medical Device Industry Coalition (FMDIC) is now an open group Manager's Choice

Health Communications Specialist

I am pleased to announce that, as the owner of this group, I have just switched us to an open discussion group. All future discussions will be fully visible, searchable, and shareable on the Web. All past discussions are now closed in a members-only archive. I look forward to our future discussions now joining the broader conversation of the wider Web.

  • Comment (6)
  • February 27, 2011
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  • Nelson T.

    Nelson

    Nelson T.

    President Texas Biostetic Instruments

    Looking for independent consultant in 510k submission help.
    doctors@chiro950.com

  • Art R.

    Art

    Art R.

    Founder and Principal Consultant at A. A. Rankis & Associates, Inc.

    510Ks and changes ...
    David,
    Question: FDA just recently published a revision to the draft guidance on When to submit a new 510k for changes.
    Is that being applied by FDA now or is the previous version still in effect until the new one goes through the public comment period?
    Please do not reply with the usual 'it reflects FDA's current thinking'. Decisions need to be made today and I believe that the existing, in-effect decision making tool is the version that has been on the books for the past bunch of years.
    Clear guidance in this will be very much appreciated.
    Art

  • David A.

    David

    David A.

    Health Communications Specialist

    I am afraid that the standard response "it reflects FDA's current thinking" is there for a very good reason. Guidance is just that: guidance. It is not legally binding. You have to comply with the statutes and regulations, not with guidance. FDA writes guidance to actually share the agency's interpretation of the statutes and regulations. So, to actually answer your question, FDA published the draft guidance for comment. The agency wants and values your opinion. But you have to go through proper channels to express your opinion. I do not work at CDRH and am not involved in the creation or future of this draft guidance. But I can assure you that as long as you comply with the Federal Food, Drug, and Cosmetic Act and Title 21 of the Code of Federal Regulations, you will likely not have troubles with the FDA. Remember that 483's and Warning Letters only quote observations and violations of the statute and regulations, not guidance documents. If you require additional guidance on this subject, I urge you to contact FDA CDRH DSMICA, http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/ucm142656.htm.

  • David A.

    David

    David A.

    Health Communications Specialist

    The draft guidance in question is available online at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm265274.htm.

  • Gino O.

    Gino

    Gino O.

    General Manager at Clement Clarke Holdings Ltd

    Looking for support to make class 2 medical device 510k submission

  • David A.

    David

    David A.

    Health Communications Specialist

    Gino, contact FDA CDRH DSMICA (Division of Small Manufacturers, International, and Consumer Assistance), http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/ucm142656.htm, if you require regulatory interpretation or guidance on the process. While no one in the FDA can act as a consultant, they can provide you with guidance on the process. You may also want to visit http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/ for guidance.

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