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Regulatory Misconduct Allegations

March 23, 2023

Regulatory Misconduct Allegations

 

Making unsubstantiated claims about one’s device, promoting off-label uses, and selling medical devices with uncleared/unapproved features are examples of what the U.S. FDA calls “regulatory misconduct”.  Specifically, regulatory misconduct is when a medical device manufacturer or other individuals marketing medical devices are doing so in a manner that violates the law.  The U.S. FDA has a mechanism for receiving complaints (allegations) of such misconduct.  I’ve lodged such complaints on behalf of clients, or helped them do so themselves.  Here’s an FDA webpage about how to formally lodge an allegation of regulatory misconduct.

 

In the end, FDA’s intervention (if any comes at all) will be driven commensurate with risk amidst FDA’s strained resources.  It seems that only in the riskiest of situations will FDA react swiftly; otherwise my experience is that FDA might just move the alleged violative firm higher in FDA’s routine inspection queue, or it may even seem that nothing has been done at all… Transparency from the FDA to know exactly what FDA has been done is still governed by the FOIA, so the process is one that takes time.  Further details on these dynamics are included in the foregoing link.

 

Regarding reporting to European Competent Authorities (CA), I suggest contacting the affected medical device CA(s) for direction on how each would have you report allegations of regulatory misconduct.

EU IVDR Accessory Definition Triggered for an Optional Item?

March 22, 2023

EU IVDR Accessory Definition Triggered for an Optional Item?

 

Per Europe’s IVDR, the definition of accessory for an in vitro diagnostic device’ [Article 2(4)] is definitely not invoked when the potential accessory (e.g., a barcode scanner) is an optional add-on module or peripheral.  Nor is the ‘accessory’ category triggered if the potential accessory isn’t essential to the basic functionality of a class A IVD instrument.  And conversely, nor is the accessory categorization nullified if the accessory is necessary for the IVD’s basic operation.    Instead, it is the opposite.

 

Specifically, Article 2(4) establishes that ‘accessory for an in vitro diagnostic medical device’ means an article which, whilst not being itself an in vitro diagnostic medical device, is intended by its manufacturer to be used together with one or several particular in vitro diagnostic medical device(s) to specifically enable the in vitro diagnostic medical device(s) to be used in accordance with its/their intended purpose(s) or to specifically and directly assist the medical functionality of the in vitro diagnostic medical device(s) in terms of its/their intended purpose(s).

 

Accordingly, if your intended purpose [i.e., Article 2(12), i.e., your labeled purpose] is that the potential accessory is to function in accordance with the Article 2(4) parameters, then it’s an accessory to the IVD.  You should stick closely to the Article 2(4) definition rather than alternative definitions.

 

Biological Evaluation for Reusable Devices: Shelf Life vs. Expected Life

March 22, 2023

Biological Evaluation for Reusable Devices: Shelf Life vs. Expected Life

 

Biological evaluation for reusable devices may reasonably not be focused on “shelf life”. The heart of this question hinges first on general medical device principles regarding shelf life (or lack thereof) vs. stability over the device’s lifetime.  Much can be said about that, so I won’t go too far down the rabbit hole about that here unless otherwise requested.  But in summary, it has been established that not all medical devices have, or need, a shelf life. Yet all devices have a life-cycle within which there is an “expected life” (U.S. FDA), lifetime (ISO 13485, ISO/TN 24971), expected lifetime (EU MDR), etc.

 

Accordingly, I don’t believe that ISO 10993-1:2018 clause 4.7 (“The biological safety of a medical device shall be evaluated by the manufacturer over the whole life-cycle of a medical device.“) means that shelf life is an important point of biological evaluation for any medical device.  Instead, the device’s shelf life is germane only if the device has a shelf life.

 

For example, reusable devices oftentimes don’t have or need a shelf life, but instead will always have an expected useful life.  Accordingly, clause 4.7 certainly requires understanding of the biological safety throughout a labeled shelf life if any such shelf life there may be.  But ultimately, for a reusable device, the main focus is generally on biological evaluation representative of the reusable device’s expected useful life, which factors in stability considerations such as material aging, response to reprocessing, etc.  For example, ISO 10993-1:2018 states that if a medical device is intended to change during its lifetime, then the evaluation shall consider all the different device states.  I would expand that to whenever the medical device does/can change during its lifetime.

Nonconforming Expiration Date

March 22, 2023

Nonconforming Expiration Date

 

In short, if erroneous / outdated / violative / incorrect expiry date (or other related data on the label) are within reasonable risk acceptance criteria (safety, performance, regulatory), then such product can be accepted as-is and left alone.  But if the risk acceptance criteria are exceeded, then corrective measures are needed to eliminate the nonconformity.  Such corrective measures would typically include relabeling and/or removal/recall.

EU MDR Classification of Accessories – “In Their Own Right”

March 22, 2023

 

EU MDR Classification of Accessories – “In Their Own Right”

 

As noted previously, pursuant to EU MDR Article 1 paragraphs 1 and 4, and particularly EU MDR Annex VIII.3.2, accessories for a medical device shall be classified in their own right separately from the device with which they are used.  But I received a question wondering whether an accessory’s tangential appearance in the Annex VIII classification rules alongside a parent device means that such accessory isn’t actually classified in its own right.

 

I interpret “classified in their own right” and “classified separately from the device with which they are used” to mean classified based on their own intrinsic characteristics rather than the parent device’s.  In practice, this means that the classification rules are to be applied to, and stand on their own regarding, accessories. For example, consistent with that, Rule 8 prescribes that, if an accessory is for an active implantable device, then the accessory is class III.  The fact that Class III is also the class given by this rule to the active implantable parent device doesn’t in my humble opinion undermine, or undo, or conflict with, or create an exception to, the Commission’s aforesaid implementing rule requiring that accessories be classified separately from the device with which they are used. The classification rules still stand on their own regarding accessories even if a rule happens to simultaneously address the classification of a parent device and its related accessories.

Problem Containment Actions for Controlling Regulatory Impact

March 21, 2023

Problem Containment Actions for Controlling Regulatory Impact

 

Today I received a question wrestling with the fact that problem containment actions tend to primarily focus on product containment and patient impact/risk, while not so much on containment actions aimed at controlling regulatory risk.  This reminds me of ISO 13485’s deliberate distinction between risks involving device safety/performance as differentiated from risks related to meeting applicable regulatory requirements.

 

Indeed, there’s not much available in terms of a standardized approach to managing regulatory risk.  For example, ISO 13485 and its creator ISO/TC 210 don’t (as far as I know) elaborate further on the distinction.  Likewise, ISO 14971 (as amended) and ISO/TR 24971 (as amended) are also short on this notion except regarding where the regulatory requirements are tethered to product safety, which only drives us back to the first aforementioned ISO 13485 arm of risk.

 

To help fill in the gaps, here are some examples of correction/containment steps to consider that involve regulatory risk:

 

  • Marketed device recall notices and agency notifications associated with device corrections/containment/removal.

 

  • Stock recovery (a regulatory concept patterned from the U.S. FDA).

 

  • Invalidation of pending or existing marketing authorizations.

 

  • Invalidation of existing clinical investigations, clinical data/results, or other design/developmental data that were collected for what is now an outdated / unrepresentative version of the developmental device.

 

  • Adverse event reporting if somehow not already done for the instance.

 

There could be others too. If one were to try and formalize consideration of such regulatory impacts, then that should be done via supplementing the organization’s procedures for correction/containment, for premarket regulatory authorizations, for recalls, for design/development, etc., with appropriate handshakes back and forth between them.

EU MDR Notified Body Demanding Use of Harmonized Standards

March 21, 2023

 

EU MDR Notified Body Demanding Use of Harmonized Standards

 

Your notified body seems to be employing a classic infamous misuse of harmonized standards for the MDD and/or EU MDR.  I generally advise our clients to respectfully, carefully, and legislatively, push back on such misuse.  But without seeing the full details of the nonconformity and of your particular case, it is not possible to say for sure whether such push back is for certain appropriate for your scenario.

 

In general, much has been said, for example here, regarding use of harmonized vs. non-harmonized standards. So I won’t say much more about that in this current post unless further questions are raised.  See also MDCG 2021-5 for the latest-and-greatest interpretations about this, such as the MDCG’s ultimate summation that, “...in general the use of harmonized standards is voluntary.”

 

The real legislative requirement (see for example in my prior post and in MDCG 2021-5) is for us to take into account the generally acknowledged state of the art.  That obligation is generally the same regardless of whether we are talking about the MDD or the EU MDR. Accordingly, any conformity solution should be anchored by that endeavor, especially in times like these where, so often, an updated harmonized standard isn’t yet available for a given EU MDR GSPR.  Our ultimate legislative requirement is to show conformity with the applicable GSPR, not with a harmonized standard(s).  Yet notified bodies still try to assert that harmonized standards are required.  They do that either because the notified body doesn’t understand the legislation or because it makes their job easier.

 

On that note, while it might be helpful to provide a notified body a gap analysis between your conformity solution and a harmonized standard, it remains true that lack of such a gap assessment is not a valid reason for a nonconformity.  In general, the most that is appropriate for a notified body to do is request such a gap analysis as a matter of convenience for the notified body (notwithstanding the possibility of an overreaching clause in your business contract with the notified body).  Such a gap assessment is not legislatively required and thus shouldn’t be lodged as a technical documentation nonconformity; instead, the legislation leaves us wide latitude in how we show conformity.

 

Another scenario I’ve heard about is a notified body’s request for a comparison between the GSPR conformity solution applied compared to an MDD harmonized standard.  Specifically, EU MDR conformity isn’t based on evolutionary comparison, or any other comparison, to the MDD, its Essential Requirements (ER), or standards that were harmonized for use with the MDD.  Instead, EU MDR conformity is based on showing conformity to the EU MDR and its GSPR.  Indeed, the MDD ER or harmonized standards aren’t required to be raised at all in an EU MDR technical documentation review unless the manufacturer has formally mandated itself to such an approach, like via a corresponding QMS document or regulatory strategy.

 

These are some dynamic variables that might play into your particular scenario.  You might want to consider seeking some expert assistance to be sure your next steps are the right ones.  In any event, hopefully the legislative bottom lines noted in this post will be helpful for you if you are formulating a response to such notified body gestures.

EU MDR Classification of Accessories

March 21, 2023

 

EU MDR Classification of Accessories

 

Pursuant to EU MDR Article 1 paragraphs 1 and 4, and particularly EU MDR Annex VIII.3.2, accessories for a medical device shall be classified in their own right separately from the device with which they are used.

Can multiple different devices be on a single EU MDD/MDR DoC?

March 21, 2023

Can multiple different devices be on a single EU MDD/MDR DoC?

 

For a Declaration of Conformity (DoC) to a European Directive like 93/42/EEC on medical devices or to a European Regulation such as 2017/745 on medical devices, multiple different devices may indeed be encompassed by a single DOC. The Blue Guide reminds us that a single declaration of conformity can be made up of a dossier containing relevant individual declarations of conformity.  As long as all the required fundamental DOC contents/elements (e.g., per Annex IV of 2017/745, per Europe’s common framework for marketing of products, per EN ISO/IEC 17050-1 as amended, etc.) are clearly distinguished for each subject device, then a DoC including multiple devices should be good to go.

Shelf Life Isn’t Always Required on Medical Device Labels

March 13, 2023

Shelf Life Isn’t Always Required on Medical Device Labels

 

FDA’s medical device label regulations at 21 CFR §801.18 include the language, “…Whenever the label of a medical device includes a printed expiration date…”, thereby leaving open the possibility that a medical device label might not include an expiration date.  In alignment with this, FDA’s shelf life guidance states, “…To determine if a particular device requires a shelf life and assign an expiration date, there are a number of different parameters that must be considered….For some devices…it is not reasonable to assign a shelf life…” [emphasis added.].  Accordingly, we can be confident that a shelf life isn’t always required on medical device labels.  Specifically, while sterile devices must always be labeled with a shelf life, it remains that non-sterile devices may not need one.