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  • 1.  GMP vs ISO 13485

    Posted 20-Nov-2019 09:31
    Dears,

    I have quite complex questions. In case I want to apply 510(k) or PMA one part should be also GMP, am I right? Is somewhere mentioned how complex it should be GMP? Is it necessary to submit whole documentation with all description? Or there are some exemptions that give me the possibility to submit only some parts of GMP? Is it the same for 510(k) as for PMA?

    If the company is ISO 13485 last version compliant and certificate receive from the NB which is part of MDSAP, could it be used as GMP approval or it is necessary to prepare GMP separately?

    I would like to know if I prepare all of the necessities which are mentioned on FDA website for 510(k):
    1, Device Description (incl. substantial equivalence, labeling, packaging, intended use, instruction for use)
    2, Form "CDRH Premarket Review Submission Cover Sheet"
    3, Form "Indications for Use Statement"
    4, Form "Truthful and Accuracy Statement"
    5,  "design input guidelines" (regarding 820.30(c)) for setting requirements.
    6,  "design output guidelines" (regarding 820.30(d)) for testing requirements.
    7,  "design review guidelines" (regarding 820.30(e)) are for managing development.
    8,  "Medical Device Reporting guidelines" (21 CFR Part 803), how we report incidents caused by our Medical Device.

    Should I submit also the whole GMP or just some part is enough if it is the same for PMA and if the MDSAP ISO certificate can help me with GMP compliance.

    Thank you

    Best Regards

    Lukas Peter

    ------------------------------
    Lukas Peter, Ph.D.
    VSB-Technical University of Ostrava
    Ostrava
    Czech Republic
    ------------------------------


  • 2.  RE: GMP vs ISO 13485

    This message was posted by a user wishing to remain anonymous
    Posted 22-Nov-2019 09:13
    This message was posted by a user wishing to remain anonymous

    510(k) and PMA are very different and for very different risk devices. In a 510(k), you do not submit any SOPs or procedures; you submit the information necessary to demonstrate safety and effectiveness of your device, and substantial equivalence to the predicate. This usually involves submitting testing for compliance to standards depending on the device. Most likely with a 510(k), you will utilize content from your design history file and verification/validation activities for some processes (cleaning, sterilization, etc.). Once 510(k) cleared, you have to register and list your device prior to marketing. Once registered with FDA, you have essentially stated you have an FDA compliant quality system and are ready for inspection. FDA will review your quality system during an inspection; inspection will determine compliance with QSR; depending on the device, that inspection might occur shortly after registration, 2 years after registration, or if OUS, maybe not for 10 years after registration.

    For a PMA, the submission is much more robust, and will include more quality system documentation. Also, PMAs include a pre-approval inspection. So for the PMA, FDA will inspect your facility before approving your device for marketing.
    Original Message


  • 3.  RE: GMP vs ISO 13485

    Posted 25-Nov-2019 07:35
    Thanks for your query; I have been looking for answer for similar question. Where does Medical Device industry stand in terms of Quality system? Does the firm with ISO 13485:2016 also need to comply with GMP certification?

    Thank you,
    Bhagya

    ------------------------------
    Bhagya Munagoti
    QA Manager & Regulatory Lead
    Cranleigh
    United Kingdom
    ------------------------------

    Original Message


  • 4.  RE: GMP vs ISO 13485

    Posted 25-Nov-2019 09:36

    There is a little ambiguity with the term GMP. I infer you mean FDA's Quality System Regulation, QSR, in 21 CFR Part 820.

    The second is the word certification. In general, a device manufacturer does not receive a certification for QSR.

    If a company markets a medical device in the US the company must have (with some limited exceptions) a quality system that satisfies QSR regardless of any other quality system.

    If a company markets a medical device in some other countries, the company must have a quality system the satisfies ISO 13485:2016 or a regional variant (EN ISO 13485:2016 for example) regardless of any other quality system. In most cases the company needs a certificate from an accredited organization to demonstrate conformity.

    There are a few twists on this.

    Sometimes non-US countries require a certificate from the FDA.

    If a company has a successful MDSAP audit, then FDA will take the company of the inspection list. This doesn't change the requirement to implement QSR.

    FDA announced a plan to consider using ISO 13485:2016, but recently pushed the date out.



    ------------------------------
    Dan O'Leary CQA, CQE
    Swanzey NH
    United States
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    Original Message


  • 5.  RE: GMP vs ISO 13485

    Posted 26-Nov-2019 01:38
    Dear Dan,

    Thank you very much. This is very helpful.

    Best Regards

    Lukas

    ------------------------------
    Lukas Peter
    Ph.D.
    Ostrava
    Czech Republic
    ------------------------------

    Original Message


  • 6.  RE: GMP vs ISO 13485

    Posted 26-Nov-2019 02:29
    Thanks Dan, that's helpful.

    Bhagya

    ------------------------------
    Bhagya Munagoti
    QA Manager & Regulatory Lead
    Cranleigh
    United Kingdom
    ------------------------------

    Original Message


  • 7.  RE: GMP vs ISO 13485

    Posted 26-Nov-2019 08:14
    Do not forget that part of being able to market a device is facility registration. Once your facility is registered, it is open for FDA inspection for compliance to cGMP (21CFR820 and other applicable parts). It is likely that this could trigger a pre-submission inspection so you want to do this when you are close to making your submission.

    Once you are listed your can make your product submission. If it is approved/cleared, then you will have a product listing under your facility.

    This is similar to the rest of the world...you get a certification to ISO 13485, then you work with the notified body to be able to put a CE mark (for EEA) or make other submissions to be able to market your product.

    Hope this helps!

    ------------------------------
    Regards,
    Mark Swanson, ASQ CBA, CMQ/OE, CQE ASQ, MBA
    Becker MN
    United States
    ------------------------------

    Original Message


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