Regulatory Open Forum

 View Only
Expand all | Collapse all

Class I exept - US vs EU?

  • 1.  Class I exept - US vs EU?

    Posted 27-Jul-2016 10:35

    I'm largely ignorant of how Class I devices get on the market and then what happens next.  I typically work with Class III, and sometimes Class II.  However, I've started running into early-phase start-ups with a basic technology that could be developed for use with a range of indications.  It's great if they can get on the market with Class I indication quickly and start generating revenue to support future develop of other indications with a higher regulatory burden.

    That much, I know.  Where I'm challenged is the question of US or EU first, especially because lack of transparency in the EU means you don't really know how it works until you go through it.  Are there any regulatory costs (and I mean real regulatory costs, like filing fees and NB fees, not product development costs like testing) associated with either path?  Do you even need an NB in the EU?  If so, do they eventually come look at the tech file?  Is this typically done annually?  I think you would pretty much have to be ISO 13485 certified, right?

    On the US side, does anyone have experience with how soon/frequently you are really likely to get inspected by FDA if you make ONLY a Class I (exempt) device or devices?  And how soon this is likely to happen after first listing?

    Any other information that might help me advise clients on the US vs EU question for a Class I (exempt) would be much appreciated!

    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Durham, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com
    ------------------------------


  • 2.  RE: Class I exept - US vs EU?

    Posted 27-Jul-2016 11:33
    Julie,

    All your questions are covered in my training/educational seminars.

    I will address few points, generally speaking.

    EU - class I devices

    - if it is a sterile or measuring device - NB needed with fees
    - if it is not sterile/measuring device - NO NB needed/no fee; DOC by the manufacturer

    US - inspection for class I exempt

    - Note: Per FDASIA 2012, FDA inspection is risk-based
    - Class I (510(k)-exempt) - exempt from the majority of CGMP requirements under 21 CFR 820 except the records/reports (several class I devices are subject to design control)
    - FDA inspection frequency for class I/510k exempt - reasonable to expect every 2-3 years unless triggered by cause

    For discussion, you may call me at 540-798-5000

    Thank you.  

    s/ David
    ______________________________________________
    Dr. David Lim, Ph.D., RAC, ASQ-CQA 
    Phone (Toll-Free): 1-(800) 321-8567



    "Knowledge is power only when it is practiced and put into action." - Regulatory Doctor

    NOTICE: This communication (including any attachments) may contain privileged or confidential information intended for a specific individual and purpose, and is protected by law. If you are not the intended recipient, you should delete this communication and/or shred the materials and any attachments and are hereby notified that any disclosure, copying or distribution of this communication, or the taking of any action based on it, is strictly prohibited.





  • 3.  RE: Class I exept - US vs EU?

    Posted 27-Jul-2016 22:03

    David, thanks for your input.  That clarifies a major source of my confusion.  I hear about Class I's being "self-certified" for CE Marking, but also was thinking I had seen references to NB oversight.  So now I know what's behind that.

    I must say I'm bit doubtful about the inspection frequency for a company that makes only Class I's, because inspections are risk-based and FDA's resources are limited.  In my limited knowledge, FDA tends to get around to Class II companies only every three years.

    On the other hand, for Class I devices that are mostly exempt from everything (per Dan's comment), there doesn't seem to be much to inspect, so maybe they can knock out clusters of geographically proximate Class I companies pretty quickly.

    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Durham, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com



  • 4.  RE: Class I exept - US vs EU?

    Posted 28-Jul-2016 10:44
    Julie

    As for inspection frequency, I've stated "reasonable to expect..."  In reality, FDA may not show up even in 4-5 years to some manufacturers. But I discern between "what should be reasonable to expect for adequate FDA inspection preparation/readiness purposes and when an inspection can actually occur..."

    I've had two clients who have inspected with surprise.

    As for "mostly exempt from everything (per Dan's comment)", class I manufacturers are still subject to Records and Reports under 21 CFR Subpart M (DMR, DHR, QS record and complaint files).

    Since complaint files must be interfaced with RM, CAPA, MDR and UDI requirements, it would be reasonable for class I manufacturers to figure out how to best establish their QMS under 21 CFR Part 820 in the US or EU (EN ISO 13485:2012). 

    Class I manufacturers tend to ignore/miss applicable regulatory requirements that should be adequately interfaced with.

    Thank you.  

    s/ David
    ______________________________________________
    Dr. David Lim, Ph.D., RAC, ASQ-CQA 
    Phone (Toll-Free): 1-(800) 321-8567



    "Knowledge is power only when it is practiced and put into action." - Regulatory Doctor

    NOTICE: This communication (including any attachments) may contain privileged or confidential information intended for a specific individual and purpose, and is protected by law. If you are not the intended recipient, you should delete this communication and/or shred the materials and any attachments and are hereby notified that any disclosure, copying or distribution of this communication, or the taking of any action based on it, is strictly prohibited.





  • 5.  RE: Class I exept - US vs EU?

    Posted 28-Jul-2016 11:14

    David,

    Am I misreading your characterization of Class I device requirements?

    I think you are suggesting that, in general, Class I devices don’t need full QSR, but only Subpart M.

    I believe the vast majority of Class I device, by Product Code, are 510(k) exempt, but not GMP exempt.

    Consider some examples.

    Product Code MPO, an Infant Heel Warmer, is a Class I device that requires a 510(k), and is not GMP exempt.

    Product Code KHY, a safety walk cane, is a Class I device that is 510(k) exempt and GMP exempt. The GMP exempt has the statement “This device is also exempted from the GMP regulation, except for general requirements concerning records (820.180) and complaint files (820.198), as long as the device is not labeled or otherwise represented as sterile.” I find this as the usual qualifier for GMP exempt devices.

    Product Code JDT, a bone cap, is a Class I device that is 510(k) exempt but not GMP exempt.

    ------------------------------
    Dan O'Leary
    Swanzey NH
    United States



  • 6.  RE: Class I exept - US vs EU?

    Posted 28-Jul-2016 11:48
    Hi Dan,

    I trust you are doing well.

    FDA inspectors/investigators are instructed to assess GMP compliance for class I manufactures as follows.

    "All Class I devices, including those exempted from most of the Quality System regulation requirements, must comply with record keeping requirements and
    complaint file requirements, as well as reporting requirements under the MDR regulation. Class I manufacturers should not be routinely scheduled for inspection
    but should receive lowest inspectional priority unless addressed by a special, "For Cause" assignment or when a health hazard is apparent...."

    My comments reflect FDA's current policy on the inspection to the class I manufacturers in view of CPGM, IOM, and 21 CFR Part 820, etc.

    Thank you. 

    David





  • 7.  RE: Class I exept - US vs EU?

    Posted 28-Jul-2016 13:42

    Dan, I think if you go back and read your original post, you will see that David was simply expanding on the QSR requirements for those Class I devices that you described as "mostly exempt from everything," to include "nearly all of QSR," by specifying those few parts of the QSR that those "mostly exempt from everything" devices were most likely to NOT be exempted from.

    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Durham, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com



  • 8.  RE: Class I exept - US vs EU?

    Posted 28-Jul-2016 12:38

    I suspect frequency of inspection may depend a bit on the district. The last experience I had directly was out in California, and it was not at all unusual for FDA to go 5-6 years between inspections for Class 1 only firms at that time. Anecdotally the local office here in MN hits them more frequently (I don't have direct experience but have some friends who do) but still probably averages in the 3+ years time frame. California also had a "state FDA" that inspected a little more frequently - about every 3-4 years.

    g-

    ------------------------------
    Ginger Glaser RAC
    Vice-President, Quality and Regulatory Affairs
    Maplewood MN
    United States



  • 9.  RE: Class I exept - US vs EU?

    Posted 28-Jul-2016 13:50

    I have received input from one other RA professional who also reported 6 years and counting for an FDA inspection of a Class I facility.

    Really, if I were FDA, I wouldn't aim for any more frequent than 5 years.  At least, not unless Congress increased its budget way beyond what it is now.  And maybe even not then. Most Class I's, I see them like the traffic laws that the police don't bother to enforce (e.g., signal a turn at least x yards before turning), but come into play only if failure to comply causes an accident.

    I think the biggest risk with an uninspected Class I (and indeed, perhaps the only real reason to inspect) is that over time it might morph into something that is no longer Class I.

    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Durham, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com



  • 10.  RE: Class I exept - US vs EU?

    Posted 29-Jul-2016 23:14

    I received another report of 5 years since the last inspection, plus an observation that FDA's budget for inspection of Class I devices is $0.  And Ginger is not alone in thinking that there may be some geographical differences in frequency of inspections, which reflect differences in FDA resources available from district to district around the country.

    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Durham, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com



  • 11.  RE: Class I exept - US vs EU?

    Posted 31-Jul-2016 18:02

    FDA Inspections, at least in this part of the world (new England), remain unpredictable.

    Examples … I have been involved with FDA inspections of class I devices and two companies that were inspected after they had gone out of business (FDA did not know, but went through the motions and conducted a somewhat abbreviated inspection) and for one of the companies another

     inspector showed up again 6 months later, said "oops", but  issued a 482 and "inspected" again. Also, component/RM suppliers and a company that makes devices for export only have been inspected: other companies have not seen FDA for years. In one case FDA appeared, unannounced, expecting to see a pharma company (it was a device company).

    My point … although all these are somewhat uncommon, they do occur.

    Art

     






  • 12.  RE: Class I exept - US vs EU?

    Posted 28-Jul-2016 13:10

    Also, thanks for your kind offer to discuss.  At this point, the only contact is from what I call "pre-start-ups," with a bright idea and no money.  So for now, it's a general question in need only of a general answer.  If any of them actually get started up (i.e., can pay me to pursue this question in detail for them), I will need to be more specific, and I may well take you up on that offer!

    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Durham, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com



  • 13.  RE: Class I exept - US vs EU?

    Posted 29-Jul-2016 13:22
    Julie,

    Based on tone of your questions, I presumed you may be answering to potential client's questions.  

    During pre-start up phase, it is reasonable to perform "regulatory shopping."  I suppose you will provide some actionable direction so that your prospective client can make an informed decision when they are funded.

    If you have special questions, you may call me at the number provided. 

    David





  • 14.  RE: Class I exept - US vs EU?

    Posted 27-Jul-2016 16:07

    My first recommendation is to stop using the term exempt, because it is ambiguous. In the US a Class I device could be exempt from:

    pre-market submission

    design controls

    Nearly all of QSR

    UDI

    In the EU, under the MDD there are no exemptions, only addition requirements for devices sold sterile or have a measuring function. These are often called Class Is and Class Im.

    In the US, classify the device by finding the Product Code. That will tell you all of the things related to marketing and production except the design control application. You will need to implement 803, 806, 807 for registration and listing, and 820.

    I infer this is not an in vitro device, so covered by the EU MDD. You need to classify the device following Annex IX. Work your way through the rules as if they were a flow chart. Document every applicable rule by number and the associated class. At the end, you picked highest class. Assume it is Class I and the device is not shipped sterile and does not have a measuring function. In that case, you will follow Annex VII. This means a technical documentation that demonstrates the device satisfied the Essential Requirements in Annex I including the Clinical Evaluation in Annex X. On June 30, 2016, Clinical Evaluation became much harder because of MedDev 2.7/1 Rev. 4. Create a Declaration of Conformity and apply the CE Mark. A Notified Body is not involved so there will not be any numbers next to the CE Mark. You will also have to implement the vigilance system in MedDev 2.12-1. You will also need to hire an Authorized Representative in the EU.

    Annex VII does not require a QMS, but I recommend implementing EN ISO 13485:2012.

    In my opinion, the Clinical Evaluation is a deal breaker for the EU. For example, “The evaluators should have at least the following training and experience in the relevant field: a degree from higher education in the respective field and 5 years of documented professional experience; or 10 years of documented professional experience if a degree is not a prerequisite for a given task.”

    ------------------------------
    Dan O'Leary
    Swanzey NH
    United States



  • 15.  RE: Class I exept - US vs EU?

    Posted 27-Jul-2016 23:36

    Dan, thanks for your comments also.  Point well taken on "exempt," although with many startups, the only exemption that seems to be of interest is...no 510(k).  Granted, that's often because they haven't heard much of anything about the others.

    I have yet to come across a situation in which ISO13485 certification was not a good idea.

    I think the CER is likely to be a deal breaker when the principals are engineers.  When they are academic medical researchers, to them it's just another clinical review article, and often the only part of process that they are comfortable with.

    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Durham, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com



  • 16.  RE: Class I exept - US vs EU?

    Posted 28-Jul-2016 07:18

    Here is my favorite guide for getting Class I devices into MDD compliance:

    Don't forget Step 6: notification to all applicable national Competent Authorities in Europe. Not all authorities require Class I products on their market to be notified, but several do. This can involve notification in a national database, potentially in a local language.

    http://ec.europa.eu/DocsRoom/documents/10272/attachments/1/translations/en/renditions/native

    Europa remove preview
     
     
     
    View this on Europa >
    ------------------------------
    Oliver Bisazza
    Director, Regulatory Policy, EMEA
    Medtronic



  • 17.  RE: Class I exept - US vs EU?

    Posted 28-Jul-2016 13:14

    Oliver, thank you for that information!  Until now I was under the impression that Class I's can really operate pretty much off the regulatory radar in the EU.

    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Durham, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com



  • 18.  RE: Class I exept - US vs EU?

    Posted 28-Jul-2016 07:51

    Hi Julie

    Your statement of "real fees, not testing costs" is interesting.  EMC testing for example is around $20,000 all in. General safety testing is more than that. Cleaning and disinfection validation studies for reusable devices , even for Class 1 devices is expensive. Usability studies if outsourced can be very expensive.

    To be compliant with the requirements of  the Essential Requirements of the MDD, companies need to have an idea of these  "unreal" fees.

    Good luck!

    Ginger Cantor, MBA, RAC
    Centaur Consulting LLC centaurconsultingllc@gmail.com






  • 19.  RE: Class I exept - US vs EU?

    Posted 28-Jul-2016 13:31

    Certainly a company that wants to put a new product on the market needs to be aware of all of the costs associated with that effort, but those costs are design costs (verification and validation).  They are not regulatory fees.

    If a client isn't knowledgeable about design, I refer to them to design firms to get those cost estimates, just as I refer them to contract manufacturers to get estimates of manufacturing-related costs if they are not sufficiently knowledgeable in that area to estimate these costs themselves, and/or to marketing firms to get estimates of marketing-related costs.

    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Durham, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com



  • 20.  RE: Class I exept - US vs EU?

    Posted 28-Jul-2016 09:46

    Hi Julie, 

    I have experience dealing with class I and some class II devices, both in US and EU. Here are my thoughts to add to the discussion already ongoing: 

    1. EU - As already mentioned, EU class I without a measuring or sterile function only requires the manufacturer to maintain technical documentation showing that the product meets all essential requirements applicable to it from the Directives that apply to it (MDD, AIMD, IVDD,depending on type of device). Once the technical documentation is ready, manufacturer then prepares a Declaration of Conformity to declare compliance to the directive (that's where the term "self certified" comes from). I always recommend getting EN13485 certified since for a significant number of essential requirements, Manufacturers  can rely on EN13485 certification for conformity assessment.

    2. USA - As Dan mentioned, the word exempt could mean different things for Class I devices depending on the type of device. For instance:

    * Most Class I devices are exempt from premarket notification (but some "reserved devices" are not)

    * Most Class I devices are exempt from Design Controls (except certain devices specified in §820.30(a)(2))

    * Some Class I devices are also exempt from GMP, except Record Keeping and Complaint Handling.

    * Some Class I devices are not exempt from design controls, eg. devices containing automated software and devices listed in the regulation §820.30(a)(2).

    Another point to note is that it is important to go through the classification rules for each country, since there are examples of devices that may be Class I in USA but Class IIa or higher in EU, and Vice Versa. Ceiling Mounted Surgical Lights are one such example (Class II in USA, Class I in EU). 

    Hope this helps! 

    Manan

    ------------------------------
    Manan Hathi RAC
    Regulatory Affairs Specialist
    Flower Mound TX
    United States



  • 21.  RE: Class I exept - US vs EU?

    Posted 28-Jul-2016 17:46

    Manan, thanks for your input.  It seems clear that when it comes to advising clients about Class I devices, as with other classes, one size will not fit all.

    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Durham, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com



  • 22.  RE: Class I exept - US vs EU?

    Posted 28-Jul-2016 12:36

    Hi Julie,

    A couple of links that is useful below.  First one I believe Oliver already posted.  Talks about what steps the manufacturer should take prior to marketing a class I device in EU.  Second one lists the medical devices Class I and II that are exempt from submissions currently (feels like it changes all the time).  That being said, just because it is exempt from 510(k) doesn't mean it is exempt from 21 CFR 820 or other requirements.

    DocsRoom - European Commission

    Europa remove preview
    DocsRoom - European Commission
    DocsRoom - European Commission
    View this on Europa >

    EU: DocsRoom - European Commission

    Medical Device Exemptions 510(k) and GMP Requirements

    Fda remove preview
     
    Medical Device Exemptions 510(k) and GMP Requirements
    Introduction Following is a breakdown of 510(k) exempt and Good Manufacturing Practice (GMP)/Quality System exemptions listed by device class. All devices in this list are 510(k) exempt unless further qualified by a footnote. Only devices annotated by (*) are also exempt from GMP except for general recordkeeping requirements and compliant files.
    View this on Fda >

    Hope it helps,

    ------------------------------
    Clarisa Tate
    Medical Device, RA & QA
    Bay Area, CA
    USA



  • 23.  RE: Class I exept - US vs EU?

    Posted 28-Jul-2016 17:47

    Thanks, Clarissa.  Links appreciated!

    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Durham, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com



  • 24.  RE: Class I exept - US vs EU?

    Posted 28-Jul-2016 13:30

    Dear July:

    David right with the classification for sterile and devices with measuring function.   With all other devices you do not need a NB and you do not need a EN ISO 13485 certified QMS.   The medical device industry in the EU is regulated with the MDD and applicable MEDDEV  standards.  Those standards need to established within your QMS.  Assuming that you do not have a sterile or measuring device, the process for entering the market is:

    Having all applicable  processes in place including Design Control and Vigilance system.  You have to generate a Technical File demonstrating compliance to the Essential Requirements  and issue a declaration of conformance.  After this is completed you can self certify your device and theoretically sell in the EU.  But you need additional action to do so.  You need a Authorized European Represent, (about $3000 annual fee + hourly fee for additional work.   You need to register your device in each country you are planning to sell with the competent authority in each member state.  Your AER is typically do this for you with charging you the hourly fee.  That sound complicated but compare to the US much more efficient form cost and time perspective.  I have brought many devices into Europe and would love to discuss with you if and how I could help you.

    Best,

    Armin

    925-212-7683 

    ------------------------------
    Armin Beck
    CEO
    SunTrixConsulting LLC
    El Dorado Hills, CA
    1-925-212-7683
    armingbeck@aol.com



  • 25.  RE: Class I exept - US vs EU?

    Posted 28-Jul-2016 17:49

    Thanks, Armin, both for the info and offer of assistance.  As I explained to David above, right now the startups I have talk to are not yet started up.  If and when they do, then I'll know what type of assistance I might need.

    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Durham, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com



  • 26.  RE: Class I exept - US vs EU?

    Posted 29-Jul-2016 12:50

    Very useful discussion everyone with lots of great information. I really found the links provided by Oliver and Clarissa very helpful. Thanks you for sharing!

    Does anybody know if these links can be used for IVDs or are there any other IVD specific resources?

    ------------------------------
    Virginia Anastassova RAC
    Manager Regulatory Affairs, Senior QA Specialist
    Starfish Medical
    Victoria BC
    Canada



  • 27.  RE: Class I exept - US vs EU?

    Posted 29-Jul-2016 14:51

    Can anyone point me to labeling requirement for Class 1 devices, both on the device and the accompanying paperwork, for USA and EU?

    ------------------------------
    Samir Shah
    Miami FL
    United States



  • 28.  RE: Class I exept - US vs EU?

    Posted 05-Sep-2016 14:22

    I'm attaching a table I put together in an effort to consolidate the information I received in comments from this forum, in a medical device LinkedIn group, and on an individual basis.

    Further review, comments, clarifications, and corrections welcomed.

    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Durham, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com



  • 29.  RE: Class I exept - US vs EU?

    Posted 06-Sep-2016 09:33

    Thanks Julie for your summary of US and EU Requirements for Class I Devices.

    I suggest one update; the Class I GUDID (and Labeling) Compliance Date is Sep 24, 2018 not 2020. If Direct Marking applies, it has a Compliance Date of Sep 24, 2020.

    ------------------------------
    Gary Saner
    Sr Mgr, Information Solutions - Life Sciences
    Reed Technology
    Horsham PA
    United States



  • 30.  RE: Class I exept - US vs EU?

    Posted 06-Sep-2016 19:56

    Thanks, Gary.  I will update and repost when I get a chance.  In the meantime, everyone reading this thread, take note!

    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Durham, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com



  • 31.  RE: Class I exept - US vs EU?

    Posted 07-Sep-2016 09:20
      |   view attached

    Hi Julie

    you may find the attached document useful.

    Best regards

    Barbara

    ------------------------------
    Barbara Drago
    Rødovre
    Denmark



  • 32.  RE: Class I exept - US vs EU?

    Posted 08-Sep-2016 11:26

    Thanks, Barbara. This looks like an interesting document.  It seems to have been prepared in an effort to address the age-old question of whether the US or EU system results in safer devices. 

    It also seems to address the difference from an EU perspective, which I think makes it a particularly nice resource if you are in the EU, given that so much that is written about the US system is written from a US perspective.  A number of people who responded to my query assumed I was asking for a US-based client, since I'm US-based, but in fact the question is as likely to be asked by an EU client who is uncertain of the US regulatory process.

    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Durham, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com



  • 33.  RE: Class I exept - US vs EU?

    Posted 08-Sep-2016 11:40
    Julie,

    FYI:

    The document states "There is no explicit requirement for post market surveillance in the USA legislation." See Conclusions Under Section 11.  This is not accurately stated.  

    Thank you.

    s/ David
    ______________________________________________
    Dr. David Lim, Ph.D., RAC, ASQ-CQA 
    Phone (Toll-Free): 1-(800) 321-8567



    "Knowledge is power only when it is practiced and put into action." - Regulatory Doctor

    NOTICE: This communication (including any attachments) may contain privileged or confidential information intended for a specific individual and purpose, and is protected by law. If you are not the intended recipient, you should delete this communication and/or shred the materials and any attachments and are hereby notified that any disclosure, copying or distribution of this communication, or the taking of any action based on it, is strictly prohibited.





  • 34.  RE: Class I exept - US vs EU?

    Posted 08-Sep-2016 22:57

    I can't speak to what it might say in the FD&C Act, because I don't like reading the Act.

    Whether or not it is explicitly required by legislation, I would say that the medical device industry doesn't have any meaningful post-market surveillance in the US at this time.  I think it is probably coming soon, and in a big way, but, for now, still waiting.

    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Durham, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com



  • 35.  RE: Class I exept - US vs EU?

    Posted 09-Sep-2016 11:41
    Julie,

    "...I would say that the medical device industry doesn't have any meaningful post-market surveillance in the US at this time...."

    I overwhelmingly wonder what has made you state "not have any meaningful post-surveillance in the US at this time."

    Your further elaboration would be appreciated. 

    D





  • 36.  RE: Class I exept - US vs EU?

    Posted 09-Sep-2016 20:27

    Surveillance is a lifeguard on a high seat with pair of binoculars and a wide view, scanning the ocean constantly for any sign of potential threat to swimmers, so that, at the first sign of trouble, he or she can blow the whistle or leap into the water, to take preventive action.

    What passes for post-market surveillance in the US is not scanning for anything, but only reacting when someone reports a problem, such as the body of a drowning victim has just washed up on the beach.

    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Durham, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com



  • 37.  RE: Class I exept - US vs EU?

    Posted 09-Sep-2016 07:50

    Dear Mr. David Lim

    I do agree that the statement "There is no explicit requirement for Postmarket surveillance in the USA legislation..." in my attached document (RIVM Letter report 2015-0001) is not accurately stated.

    In fact Section 522 of the US Federal Food, Drug and Cosmetic Act (the Act), the new Postmarket Surveillance guidance (Issued on May 16, 2016) under Section 522 of the Federal Food, Drug, and Cosmetic Act and CFR 21 Part 822 Subpart C in my opinion give a comprehensive description of the Postmarket surveillance process in USA.

    The References section (ref. #44. and #47.) of my attached document do include ref. to the above mentioned FDA docs, however it can still be asked the meaning of the statement "...no explicit requirement for Postmarket surveillance in the USA legislation...".

    Thank you for giving us the opportunity to learn from your comment.

    Sincerly,

    Barbara Drago

    ------------------------------
    Barbara Drago
    Rødovre
    Denmark



  • 38.  RE: Class I exept - US vs EU?

    Posted 09-Sep-2016 11:45
    Barbara,

    I was expecting some professionals might/would fiercely oppose to my statement.  

    Counter-intuitively, you've invested in your time and rather verified the statement.

    Your kindness and professional approach would be respectfully noted.   

    Thank you.

    s/ David
    ______________________________________________
    Dr. David Lim, Ph.D., RAC, ASQ-CQA 
    Phone (Toll-Free): 1-(800) 321-8567



    "Knowledge is power only when it is practiced and put into action." - Regulatory Doctor

    NOTICE: This communication (including any attachments) may contain privileged or confidential information intended for a specific individual and purpose, and is protected by law. If you are not the intended recipient, you should delete this communication and/or shred the materials and any attachments and are hereby notified that any disclosure, copying or distribution of this communication, or the taking of any action based on it, is strictly prohibited.





  • 39.  RE: Class I exept - US vs EU?

    Posted 09-Sep-2016 20:12

    "There is no explicit requirement for post market surveillance in the USA legislation."

    If this is what you are referring to, I wouldn't consider it an explicit requirement for post-market surveillance:

    "Section 522 of the Act, 21 U.S.C. § 360l, authorizes FDA to require postmarket surveillance…"

    To me this is just an option that is open to FDA under the Act. If there were an explicit requirement in the Act, FDA would not need to require it, because it would already be required.

    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Durham, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com



  • 40.  RE: Class I exept - US vs EU?

    Posted 09-Sep-2016 20:54
    Julie,

    Sec. 522 of the Act should be interpreted as required (e.g., statutory requirements) unless it is exempted. Current FDA policy is risk based and the FDA requires some device manufacturers to conduct PASs.   

    If paraphrased, it may be viewed as optional from FDA side but not from industry's.

    A firm can be required to perform PASs by the FDA/DHHS (e.g., jump) at any time per the Sec. 522.

    Thank you.

    s/ David
    ______________________________________________
    Dr. David Lim, Ph.D., RAC, ASQ-CQA 
    Phone (Toll-Free): 1-(800) 321-8567



    "Knowledge is power only when it is practiced and put into action." - Regulatory Doctor

    NOTICE: This communication (including any attachments) may contain privileged or confidential information intended for a specific individual and purpose, and is protected by law. If you are not the intended recipient, you should delete this communication and/or shred the materials and any attachments and are hereby notified that any disclosure, copying or distribution of this communication, or the taking of any action based on it, is strictly prohibited.





  • 41.  RE: Class I exept - US vs EU?

    Posted 10-Sep-2016 04:01

    GHTF has a document that provides a comparative analysis of post-marketing surveillance systems in Australia, Canada, US, Japan, and the EU.

    It is GHTF/SG2/N47R4:2005 Review of Current Requirements on Postmarket Surveillance

    ------------------------------
    Dan O'Leary
    Swanzey NH
    United States



  • 42.  RE: Class I exept - US vs EU?

    Posted 10-Sep-2016 14:15

    Then it would seem that the report is correct when it says that "There is no explicit requirement for post market surveillance in the USA legislation, although the FDA can require this for specific devices."

    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Durham, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com



  • 43.  RE: Class I exept - US vs EU?

    Posted 10-Sep-2016 14:25
    Julie,

    The term "explicit" means "...stated clearly and in detail, leaving no room for confusion or doubt..."

    The FDA can require some device firms to perform PASs per Section 522.

    FDA has statutory/legal authority to require PASs to some device firms at any time per Section 522, FDCA, stating clearly and leaving no room for confusion.

    :-)

    Thank you.

    s/ David
    ______________________________________________
    Dr. David Lim, Ph.D., RAC, ASQ-CQA 
    Phone (Toll-Free): 1-(800) 321-8567



    "Knowledge is power only when it is practiced and put into action." - Regulatory Doctor

    NOTICE: This communication (including any attachments) may contain privileged or confidential information intended for a specific individual and purpose, and is protected by law. If you are not the intended recipient, you should delete this communication and/or shred the materials and any attachments and are hereby notified that any disclosure, copying or distribution of this communication, or the taking of any action based on it, is strictly prohibited.





  • 44.  RE: Class I exept - US vs EU?

    Posted 11-Sep-2016 07:52
    FDA thus far has been very judicious in its Section 522 requests.  We have proactively requested them when it could shift some premarket substantiation re



    Sent from my Verizon, Samsung Galaxy smartphone





  • 45.  RE: Class I exept - US vs EU?

    Posted 11-Sep-2016 07:55
    FDA thus far has been very judicious in its Section 522 requests.  We have proactively requested them when it could shift some premarket substantiation requirements to postmarked confirmation.  As you know FDA is charged with looking for opportunities to shift premarket burdens to post market.  So we've looked at Section 522 opportunistically.



    Sent from my Verizon, Samsung Galaxy smartphone





  • 46.  RE: Class I exept - US vs EU?

    Posted 11-Sep-2016 09:32
    Mark,

    "...FDA is charged with looking for opportunities to shift premarket burdens to post market..."

    FDA has right to do so and they are obligated to, trying to ensure that the devices are safe and perform as intended.

    It should be firms' efforts to overcome the postmarket requirement imposed by the FDA in a justifiable matter.  

    I suppose you are only referring to 522 studies as part of postmarket surveillance. 

    Thank you.

    s/ David
    ______________________________________________
    Dr. David Lim, Ph.D., RAC, ASQ-CQA 
    Phone (Toll-Free): 1-(800) 321-8567



    "Knowledge is power only when it is practiced and put into action." - Regulatory Doctor

    NOTICE: This communication (including any attachments) may contain privileged or confidential information intended for a specific individual and purpose, and is protected by law. If you are not the intended recipient, you should delete this communication and/or shred the materials and any attachments and are hereby notified that any disclosure, copying or distribution of this communication, or the taking of any action based on it, is strictly prohibited.





  • 47.  RE: Class I exept - US vs EU?

    Posted 11-Sep-2016 14:12
    Mark,

    "...So we've looked at Section 522 opportunistically..."

    For the past several years, I've tried to convince both pharma and device industry how to look at legal requirements......

    FDA issued warning letters to some firms for "failure to comply with the requirements under section 522..."

    For informational purposes only, here is one example (close out) at http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm516253.htm

    To all firms (if subjected to), application of section 522 should be practical, actionable and sustainable.  

    Your opportunistic view/approach can be risky under some circumstances, in particular when a firm's management has zero willingness to comply with the 522 requirements. 

    Thank you.

    s/ David
    ______________________________________________
    Dr. David Lim, Ph.D., RAC, ASQ-CQA 
    Phone (Toll-Free): 1-(800) 321-8567



    "Knowledge is power only when it is practiced and put into action." - Regulatory Doctor

    NOTICE: This communication (including any attachments) may contain privileged or confidential information intended for a specific individual and purpose, and is protected by law. If you are not the intended recipient, you should delete this communication and/or shred the materials and any attachments and are hereby notified that any disclosure, copying or distribution of this communication, or the taking of any action based on it, is strictly prohibited.





  • 48.  RE: Class I exept - US vs EU?

    Posted 11-Sep-2016 09:18
    Julie,

    Speaking of medical device "Post-Market Surveillance", there are many other relevant and applicable regulatory provisions.

    For example,

    21 CFR Part 803
    21 CFR Section 820.198
    21 CFR Part 821
    21 CFR Part 806
    21 CFR Part 822
    21 CFR Section 814.82
    etc.

    I provide extensive training on these topics as well as pharma relevant topics. 

    Thank you.

    s/ David
    ______________________________________________
    Dr. David Lim, Ph.D., RAC, ASQ-CQA 
    Phone (Toll-Free): 1-(800) 321-8567



    "Knowledge is power only when it is practiced and put into action." - Regulatory Doctor

    NOTICE: This communication (including any attachments) may contain privileged or confidential information intended for a specific individual and purpose, and is protected by law. If you are not the intended recipient, you should delete this communication and/or shred the materials and any attachments and are hereby notified that any disclosure, copying or distribution of this communication, or the taking of any action based on it, is strictly prohibited.





  • 49.  RE: Class I exept - US vs EU?

    Posted 11-Sep-2016 09:52
    Julie,

    Just to give you statutory basis of MDR as an example.

    The final MDR regulation is based on the SMDA1990, MDA 1992, and FDAMA 1997.  

    MDR requirements are under the section 519 of the FD&C Act.

    To read FDA MDR guidance and FDCA 519, you may refer to http://regulatorydoctor.us/medical-device-reporting-manufacturers/

    D





  • 50.  RE: Class I exept - US vs EU?

    Posted 13-Sep-2016 10:38

    In theory, yes, they can. However, in reality the requests to do so typically involve a long, drawn-out process in which it can take years before said post-market surveillance study is initiated. The exception tends to be when you submit a new 510(k) for a class of devices that already is subject to 522 orders - then you tend to get the 522 order at the same time as your clearance (or in reality, before).

    The key point for this thread through, is that most manufacturers should not expect to ever see a 522 order for their 510(k) product. The number of 510(k)s that are not subject to those orders, and likely never will be, far exceeds those that are. This is a good thing, because 522 requirements, as compared to PMS expectations in the EU, are very far apart. The vast majority of 522 protocols require studies akin to PMA studies, albeit focused on one or more specific questions.[and yes I know there are exceptions that are very limited and targeted]

    The key point, for this thread, is that PMS is expected for all devices in the EU. In the US, except for those rare 522 studies, PMS in that sense is not required - however, trending of data that is available is required under the QSR. In addition, as FDA becomes more familiar with risk management standards, they do sometimes interpret the need to update the RM files in a context similar to, but not identical to, EU PMS requirements.

    g-

    ------------------------------
    Ginger Glaser RAC
    Vice-President, Quality and Regulatory Affairs
    Maplewood MN
    United States