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  • 1.  Regulations/Standards/Guidances, etc. Monitoring

    This message was posted by a user wishing to remain anonymous
    Posted 06-Jul-2020 09:00
    This message was posted by a user wishing to remain anonymous

    We have a bit of a debate between quality and regulatory - 

    1) Who monitors and maintains Regulations/Standards/Guidances, etc? Currently, RA does this task at our company.

    2) When do they have to be purchased or downloaded? When they are published/revised?  Or some later date, (like when you have the budget). The FDA always seems to be behind in adopting their consensus standards but notified bodies, seem to want the most current standard available. 

    Thoughts on these points appreciated!


  • 2.  RE: Regulations/Standards/Guidances, etc. Monitoring

    Posted 07-Jul-2020 01:23
    You need to consider a regulatory strategy for your product line and the markets that your products are being sold in first.
    Then you need to consider what standards apply to your device types.
    You need to monitor those standards on a regular basis, at least a yearly basis if not on a quarterly basis for changes and should have a procedure in place.  Some Notified Bodies expect to see a procedure in place for this process.  I tend to ask this question when I audit my clients and also when I audit for the NB's I have worked for and the one I work for currently.
    It is good to monitor standards that are being developed as well.  
    Some companies use monitoring services and some do it all in house.  Some also hire consultants to put a list together for them which may include laws, regulations, directives, guidance, and standards that apply to your device/systems/accessories.

    If you consider consultants to help you thru the process consider those that are involved in standards development process and are in standards committees as they know what is in the pipeline and can help you find out what and when certain standards will be coming out that may help you be aware of standards that will be helpful in your development plans and strategies.

    ------------------------------
    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


  • 3.  RE: Regulations/Standards/Guidances, etc. Monitoring

    Posted 07-Jul-2020 02:10
    Hi Anon,

    There are some standardization agencies which notify you when the next revised version of a standard is published (if you have already purchased the previous version). This is a nice tracking system.
    Notified Bodies have different approached on that matter. For the MDD most of them accept the current harmonized standards. That means that many standards are not the latest versions.
    For the MDR we do not have harmonized standards yet, but even when we do, when a new standard comes up, we don't expect to be harmonized very soon. Some of the standards recommend a transition period which you can take into consideration.
    In general, most of the NBs will accept it if you stay with the current harmonized and not with the latest standard. Some of the big ones want you to go with the latest version but of course they allow a transition period.

    My recommendation is to always go with the latest version.

    As of the first question, there are a lot of companies who have a RA/QA department. It depends on the size of the company and the qualifications of the employees.
    You do not have a clear answer on that.

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

    Original Message


  • 4.  RE: Regulations/Standards/Guidances, etc. Monitoring

    Posted 07-Jul-2020 09:31
    1. Whichever one makes sense for your company. It always amazes me that somehow people think there are "right" answers to org structure and responsibility questions like this. Who has the skill set (understanding standards, which ones apply, how they work), the time to fit it into their work, the relationships with the departments that have to follow these standards? The group with the most of this should probably be responsible for it.

    2. There is no rule "per se" that they have to be downloaded - you could conceivably subscribe to a service that makes the latest copies available on demand and use that to show your NB access. That said, I think you mean "when do you need to have working copies available?" In general, this depends on your company - do you want them early so you have lots of time to transition? Do you have a current R&D project that needs it, even if it isn't fully in force yet? do you need to wait until the end of the budget year to have cash for it? That said, at the very latest you should have working copies available at the time you certify to a standard. How else could you certify you meet it if you don't even have a copy? Yes, you may have read a friends, but that is impossible to prove in an audit, not to mentin not compliant with copyright laws.

    G-

    ------------------------------
    Ginger Glaser RAC
    Chief Technology Officer
    MN
    ------------------------------

    Original Message


  • 5.  RE: Regulations/Standards/Guidances, etc. Monitoring

    Posted 10-Jul-2020 08:37
    It doesn't really matter which department performs the duty as long as it is done.  I have worked in several companies over the years, some where it is done in regulatory, some Quality and some both (where Quality in responsible for all Quality/cGMP/PQS related items and regulatory is responsible for all submission related),  In my current company we do the later, I am responsible for Quality & Pharmacopoeial Intelligence - so I cover global regs for all Quality, cGMP/GDP, pharmacopoeial items.  

    The standards, regulations, guidances should be incorporated into your QMS by the effective date.  The agencies would never accept a company saying they couldn't afford it.  If a regulation or standard etc is related to your business areas, then you have to assess it, in some cases you can do something different - but you would still need to have the standard, review and assess it and provide robust, scientific rationale on why your current practices are equivalent or better.

    ------------------------------
    Janeen Skutnikwilkinson
    Wake Forest NC
    United States
    ------------------------------

    Original Message


  • 6.  RE: Regulations/Standards/Guidances, etc. Monitoring

    Posted 12-Jul-2020 18:26
    For the budget minded, shop around for your standards! The Estonian Standards Service provides standards in English at very affordable rates:
    https://www.evs.ee/en/search

    ------------------------------
    Karen Long RAC
    Vancouver BC
    Canada
    ------------------------------

    Original Message


  • 7.  RE: Regulations/Standards/Guidances, etc. Monitoring

    Posted 12-Jul-2020 22:52
    Yes, good source to get less expensive standards is going to Estonia standards and purchase English copies but be careful what you order so you get the right copy.  Usually the Estonia national version is the same as IEC or ISO but with the European info added in front and back and in Euro's but still much cheaper than most sources.  Go to https://www.evs.ee/shop. To get a pdf that can print and be used on any computer you have to pay for 2 copies.

    ------------------------------
    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


  • 8.  RE: Regulations/Standards/Guidances, etc. Monitoring

    Posted 13-Jul-2020 05:30
    Hi. Can anyone recommend a service provider that would monitor a defined list of standards, regulations and guidance documents and provide automatic updates on when anything is updated or made obsolete? The things I'm interested in are ISO standards, USP, EP, US & EU regulations, FDA/HC guidance documents.

    ------------------------------
    Alison Jarvis
    King's Lynn
    United Kingdom
    ------------------------------

    Original Message


  • 9.  RE: Regulations/Standards/Guidances, etc. Monitoring

    Posted 13-Jul-2020 08:21
    Not really one service that covers everything that I'm aware.

    C2P https://www.complianceandrisks.com/ is working toward that goal; we use them for regulation monitoring and use IHS for standard monitoring.

    C2P is inexpensive for everything they cover, very strong on electronics but new to med device / pharma

    ------------------------------
    Joshua Lust
    Senior Quality & Regulatory Affairs Manager
    Grand Rapids MI
    United States
    ------------------------------

    Original Message


  • 10.  RE: Regulations/Standards/Guidances, etc. Monitoring

    This message was posted by a user wishing to remain anonymous
    Posted 15-Jul-2020 16:25
    This message was posted by a user wishing to remain anonymous

    For monitoring FDA guidances, I'd suggest one option that is free:

    Monitor the RSS feed for RAPS using feedly.com or another RSS collector. Whenever a new FDA guidance comes out, RAPS has a summary within a day or two. RAPS had an article on RSS feeds a few years ago:
    https://www.raps.org/regulatory-focus™/news-articles/2014/8/using-rss-feeds-as-a-regulatory-intelligence-tool-the-(updated-list-of)-feeds-you-need-to-follow.

    The RAPS RSS feed is now at (don't click on it, but add the URL to your RSS reader):
    http://www.raps.org/RSSFeed.aspx

    You can add USP to your RSS reader with this URL: https://www.usp.org/

    and so forth.

    When I joined regulatory affairs 7 years ago, I began monitoring all these sites and more via RSS feeds with the free version of feedly. It's so fast and free and it has made me quite an expert and up to date on complex regulatory matters.
    Original Message


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