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  • 1.  FDA recognized consensus standards

    Posted 11-Dec-2018 13:15
    Hello,
    I have a general question about FDA Recognized Consensus Standards. How do you typically use the standard database (Recognized Consensus Standards)?
    1. Besides the standards that are listed with the product code, do you search for other standards that FDA may require conformance to?
    2. What does Specialty Task Group, General I (QS/RM), mean? Do these apply to all medical devices. My guess is QS for Quality System and RM for Risk Management but I'm not sure. What does General II (ES/ECM) stand for?
    Thank you,

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    Maddi Myers
    Regulatory and Quality Project Manager
    Edina MN
    United States
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  • 2.  RE: FDA recognized consensus standards

    Posted 11-Dec-2018 17:23
    FDA allows manufacturers to cite certain recognized standards to meet relevant requirements in the FD&C Act. Not all standards may be recognized by FDA. For eg. ISO 14971 - Application of Risk Management is a recognized standard in the FDA's recognized standards repository whereas ISO 13485 is not.

    Besides standards specified under product codes, it is expected of manufacturers /applicants to reference all applicable recognized standards in the product application eg., 510(k) which you use for evaluating the safe and intended use of the product. For example, you may see only one recognized standard under a product code. However, you also need to reference additional recognized standards that apply to your proposed product. (standards for testing, design, sterilization, packaging, and shelf life etc.,). 

    General-1 standards are not applicable to all medical devices. Standards recognized by ES/ ECM STG are applicable for electrical equipment manufacturers.

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    Phani Puppala
    Franklin MA
    United States
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    Original Message


  • 3.  RE: FDA recognized consensus standards

    Posted 12-Dec-2018 06:05
    Maddi,

    Typically you should know the standards that are applicable to your device, i.e. sterile, electrical, OTC, etc., as there are a number of standards that can be applied.  From my experience most of the commonly recognised standards are ISO 10993, ISO 11135, ISO 14971, ES 606061-1, IEC 60601-1-2, and so on.  There are some pay for service that can assist in knowing which standards may apply to your device or using consultants that are familiar with your device type.

    1. Generally, the Product Code should list most of the specific product standards, however, it would not list applicable general standards like sterilization, biocomp, reuse, transport, etc. 
    2. The Speciality Task is the group within CDRH branches that are responsible for administering updates to the standards listed.  If you type in other standard you will get the different areas within CDRH like Gastroenterology, General Surgery, and then the General I and General II.  This is just the groups that are responsible for keeping the standards updated.

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    Richard Vincins RAC
    Vice President Global Regulatory Affairs
    Pembroke Pines FL
    United States
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    Original Message


  • 4.  RE: FDA recognized consensus standards

    Posted 12-Dec-2018 12:27
    One point that was not mentioned so far is that Recognized Consensus Standards just like FDA Guidance documents are voluntary to follow but without using these tools you will have a harder time to prove you meet <g class="gr_ gr_208 gr-alert gr_spell gr_inline_cards gr_disable_anim_appear ContextualSpelling ins-del multiReplace" id="208" data-gr-id="208">FDAs</g> minimum burden of proof expected for a submission.

    There is also a Final Guidance document for Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices issued in Sept 2018 and also a Draft Guidance document for Recognition and Withdrawal of Voluntary Consensus Standards issued in Sept 2018.

    ------------------------------
    Leonard (Leo) Eisner, P.E.
    The "IEC 60601 Guy"
    Principal Consultant, Eisner Safety Consultants
    Phone: (503) 244-6151
    Mobile: (503) 709-8328
    Email: Leo@EisnerSafety.com
    Website: www.EisnerSafety.com
    ------------------------------

    Original Message


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