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FDA Medical Device “Distributor”, “Private Label Distributor”, and Label Overview

Posted by Kevin Randall In Distributors, FDA, Labeling, Private Label Distributor 0 comment

March 13, 2023

FDA Medical Device “Distributor”, “Private Label Distributor”, and Label Overview

 

For the U.S. medical device jurisdiction, the FDA doesn’t automatically consider the person named on the label to be the manufacturer.  This is contrary to other jurisdictions like Europe’s Union and Canada.  Accordingly, for the U.S., if the person named on the label is actually just a distributor for whom a distributor-branded version of the device has been made/authorized by the product’s manufacturer or specification developer, then the FDA categorizes that named person as a “wholesale distributor”.  More specifically, FDA calls such a distributor a “private label distributor” and officially defines that as a distributor that obtains a device from a manufacturer with the label already applied and that does not repackage or otherwise alter the device’s package or label.

 

The “wholesale distributor” category is contingent on FDA’s official definition: Any person (other than the manufacturer or the initial importer) who distributes a device from the original place of manufacture to the person who makes the final delivery or sale of the device to the ultimate consumer or user.  In this definition, my understanding is that “the person who makes the final delivery” = a courier service, a 3PL, etc., while “the person who makes final sale to the ultimate user” = a retailer.  Remember also FDA’s official definitions of “manufacture” [making by chemical, physical, biological, or other procedures of a medical device (short paraphrased summary)] and “manufacturer” [any person who designs, manufactures, fabricates, assembles, or processes a finished device (short paraphrased summary)]. Ultimately, if the operations in which the wholesale distributor is engaged stray beyond the boundaries of the U.S. wholesale distributor definition and into the manufacture/manufacturer definitions, then a firm’s eligibility for the wholesale distributor categorization can become disqualified.

 

An associated U.S. label requirement [21 CFR §801.1(c)] for private label distributors is to, on the label, identify the distributor with the clarifier “Distributed by” or “Manufactured for“.  But I suggest that “Distributed by” more succinctly addresses the main intent of 21 CFR 801.1(c) because “Manufactured for” is also used for manufacturers who are specification developers.

 

Remember also that the ISO 15223-1 symbols aren’t generally required by U.S. device labeling regulation, notwithstanding possible technology-specific symbols that might be required in some cases.  Instead, the “Manufactured for” or “Distributed by” clarifier is what is required, specifically, when the person named on the label isn’t the manufacturer.  Yet if an ISO 15223-1 symbol is used for the U.S. labeling to designate the role of the person on the label, then the distributor symbol is the proper symbol for a U.S. distributor.  But you will need to reconcile this with the competing fact that, for jurisdictions like Europe and Canada where the person named on the label is by default considered the manufacturer, then the 15223-1 distributor symbol isn’t appropriate there.

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Quality Agreements – Ownership and Format

Posted by Kevin Randall In FDA QMS, ISO 13485, Quality Agreements 0 comment

March 13, 2023

Quality Agreements – Ownership and Format

 

The Quality and/or Regulatory departments need to be the primary authors of the Quality Agreement.  Yet the Quality Agreement nonetheless still needs to be corporately/legally executed between the parties.  Thus, the signatories should be executive officers in order to assure the Agreement has the necessary weight.

 

If you are working on your Quality Agreements, then kudos to you.  Those are international, including U.S. FDA, staples of proper supplier control.  While it may be tempting to conclude that Quality Agreements are just a figment of ex-U.S. ISO 13485 scenarios, U.S. FDA investigators will in fact (I’ve had it happen) ask to see your “Quality Agreements” also.  Not only is FDA already using that language in practice, the agency is only 12-24 months (my estimate) from formally putting it into its revised Quality Management System Regulation (QMSR); so don’t get caught off guard or pick a semantical fight that you won’t win with FDA.

 

Indeed, while FDA’s current QS Regulation doesn’t actually use the words “Quality Agreement” (instead using “quality requirements”, “purchasing data”, and “purchasing documents”), the fundamental intent and requirements are generally the same.  Remember that FDA’s current QS Regulation’s supplier control requirements were fashioned after ISO’s “subCONTRACTor” requirements.  And FDA and other international agencies can be preferential to the GHTF’s (Global Harmonization Task Force’s) and NBOG approach, which also push this into contractual terms.  So we are in fact talking about quality contracts (“Agreements”) here.

 

In general, Quality Agreements need to cover a number of key things such as, but not necessarily limited to:

 

  • Corrective action and preventive action, Process Validation

 

  • Acceptance and verification activities

 

  • Complaint investigational support

 

  • Supplier training/competence

 

  • Design process

 

  • Change control

 

  • Handling of non-conformities

 

  • Access for audits

 

  • and others.

 

I would recommend against getting too creative or cute when achieving the parties’ contractual agreement on these topics, especially since the world has already adopted, with FDA soon to officially follow, the “Quality Agreement” vernacular.

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DHF Documentation of Design Changes

Posted by Kevin Randall In Design & Development, Design Change, Design Control, FDA QMS, ISO 13485 0 comment

March 13, 2023

DHF Documentation of Design Changes

 

Neither the FDA nor ISO 13485 mandate a required format for the Design History File (DHF).  Accordingly, we have latitude to decide what structure, format, and organizational approach we use to meet the basic regulatory requirements and objectives for the DHF.  Accordingly, if your system does that for each type of device via a single DHF or via a composite of DHFs, then both ways can work.  Accordingly, the main focal point is instead for us to be sure that the DHF, in whatever format we use, ultimately captures those changes via proper design change principles and procedures.  Indeed, it is common and expected that the design attributes, such as the intended use or indications, might evolve, or be refined, during the design process.

 

For example, the U.S. FDA has said that we are not expected to maintain records of changes made during the very early stages of product development.  Instead, only those design changes made after the approval of the design inputs need be documented using proper design change controls.  So, as long as the evolution of your intended use and indications are properly managed and processed using proper design change controls, then you should be on solid ground.  For example, if the changes made to the intended use or indications are no longer representative of the intended use or indications for which you’ve previously completed design verification and/or validation, then those studies would need to be supplemented or redone.  As long as your DHF, in whatever form you keep it, captures this, then that would be a compliant DHF.

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FDA UDI for Class 1 510(k)-Exempt Devices

Posted by Kevin Randall In FDA, FDA Inspections, UDI 0 comment

March 10, 2023

FDA UDI for Class 1 510(k)-Exempt Devices

 

I recently received an inquiry about the UDI implications of a device that the Labeler had previously miscategorized.  FDA’s class-based UDI requirements are governed by the way FDA (i.e., the applicable U.S. classification regulation) categorizes/classifies the subject device; not by how the Labeler categorizes the subject device.  In other words, even if the Labeler had previously miscategorized its devices, then that doesn’t justify the Labeler not meeting the applicable UDI requirements.  In other words, FDA would still penalize (i.e., via Form FDA 483, Warning Letter, Untitled Letter, etc.) the Labeler for noncompliance with the UDI requirements even if the Labeler didn’t believe or understand that it was subject to those requirements.

 

Note that if the subject device is FDA Class I GMP-Exempt, then such a device is wholly exempt from UDI requirements, including the requirements to submit data to the GUDID.  In that case, the Class I device UDI compliance dates are moot.

 

If Class I but not GMP-exempt, then September 24, 2022 is the FDA enforcement discretion compliance date for the 801.18, 21 CFR 801.20, 21 CFR 801.50, and 21 CFR 830.300 requirements for those devices, rather than the original September 24, 2018 compliance date (as long as those devices are not implantable, life-supporting, or life-sustaining).

 

A three-year grace period ending September 24, 2021 (lengthened via FDA enforcement discretion to September 24, 2022) existed for Class I non-GMP-exempt devices manufactured and labeled before those devices’ original September 24, 2018 compliance date. But that three-year grace period was for existing inventories (i.e., inventories not yet sold, i.e.., existing unsold inventories of devices manufactured and labeled before those devices’ original September 24, 2018 compliance date); it doesn’t apply for devices already marketed.

 

So again ultimately, Class I devices that aren’t GMP-exempt and aren’t implantable, life-supporting, or life-sustaining, shall have complied with the 801.18, 21 CFR 801.20, 21 CFR 801.50, and 21 CFR 830.300 requirements by September 24, 2022.  In other words, if this category of devices were marketed on or after that date without conforming with these UDI requirements, then those devices are misbranded (i.e., they’re not in compliance with U.S. medical device labeling law).  That means the responsible party needs to figure out whether those misbranded units need to be recalled, or if they can instead remain in the marketplace.  That decision hinges on FDA’s recall trigger criteria; specifically, in whether it a level of misbranding against which FDA would initiate legal action, e.g., seizure, in order to maintain public health.

 

Also of note: Some UDI direct-marking requirements may have longer enforcement dates than those aforementioned, but that will require further discussion which seems to be outside the scope of our immediate question at the moment, so I’ll forego further attention to that for the time being.

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Human Factors Data from Animal Studies

Posted by Kevin Randall In Human Factors, Usability 0 comment

March 10, 2023

Human Factors Data from Animal Studies

 

First, as a general rule, my understanding is that the HF Category is intrinsically governed by the nature of the subject device and its intended use rather than the HF study method or results.  For example, HF Category 2 devices are expected by the U.S. FDA to involve no user tasks which, if performed incorrectly or not performed at all, would or could cause serious harm to the patient or user, where harm is defined to include compromised medical care.

 

In general for assessing the usability of a subject device, there could be a variety of user interface test-usage paradigms (e.g., use on humans, use on animals, or even on the bench) that could be sufficient as long as the chosen paradigm is representative of how the user interacts with the user interface.  For example, testing a user’s interaction with an electrosurgical generator and handpiece by having the user use the devices on animal tissue could be an adequate way to assess the usability as long as the testing gives appropriate consideration to relevant human factors like user characteristics, capabilities, needs, expectations, cognition, preferences, real-world demands, etc., etc.

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Health Canada: Licence Amendment vs New Licence Application

Posted by Kevin Randall In Canadian Licencing, Health Canada 0 comment

March 9, 2023

Health Canada: Licence Amendment vs New Licence Application

 

Knowing whether an existing Canadian Medical Device Licence can be amended or an entirely new Medical Device Licence is required depends on a number of critical factors/variables.  Those critical factors/variables include, but may not be limited to, the licence/device class, licence type, and the specifics of the change.  Those details need to be known in order to unravel and apply Health Canada’s corresponding licence amendment requirements.

 

Some changes can be made via relatively abbreviated amendments using an abbreviated mechanism/format offered by Health Canada, while other amendments need a full amendment using Health Canada’s full amendment format, while still other changes will indeed demand a whole new licence application altogether.  These amendment variables aren’t driven by the manner in which you keep your internal technical documentation or file; instead, they are driven by the nature of the variables themselves.

 

Also of note, when doing applications for new or amended Canadian Medical Device Licences, we don’t “designate” the applications via a cover letter; instead, we must choose and select the appropriate application type and Health Canada format corresponding to the nature of the change.  Indeed, the application type and format are what intrinsically identify the type of application.  In other words, if an applicant is planning on just using a cover letter and the applicant’s own format for the Canadian licence application rather than the proper corresponding format(s) established by Health Canada, then the application will be rejected.

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FDA 21 CFR Part 7 vs. Part 806: What’s the Difference?

Posted by Kevin Randall In FDA, Recalls, Uncategorized 0 comment

March 8, 2023

FDA 21 CFR Part 7 vs. Part 806: What’s the Difference?

 

And as you deliberate on the nature of your proposed field gesture, remember first that 21 CFR Part 806 is not the regulation for categorization, evaluation, or initiation of any recall.  Instead, FDA intends Part 806 to be for assuring proper reporting to FDA of certain recalls; specifically, class I and II recalls. FDA directly clarified this when it promulgated Part 806 after the agency received stakeholder confusion about the relationship between Part 806 corrections and removals vs. 21 CFR Part 7 recalls.

 

Indeed, 21 CFR Part 806 isn’t triggered or invoked by sending a letter to your customers.  Instead and ultimately, 21 CFR Part 7 governs firm-initiated recalls and FDA-“requested” recalls along with the associated customer notifications (while similarly, 21 CFR Part 810 governs FDA-mandated recalls).  Again, Part 806 is not for initiation of any recall, nor for the related recall or other customer communication.  Accordingly, be sure you first apply the appropriate event-triaging and planning (including customer notification) paradigms from Part 7 as a first step before tackling the separate task of deciding if a recall or safety alert is reportable to FDA under Part 806.

 

Remember also that firm-initiated recalls may not actually be reportable to FDA, in which cases the firm is responsible to decide whether the action is a recall.  FDA may later scrutinize that decision (e.g., during routine GMP inspections), but nonetheless still leaves the onus on the firm to make the appropriate categorization in real-time.

 

Another important point to consider is that “safety alerts” as defined by FDA may or may not be a recall, and thus may or may not be reportable to FDA under Part 806.  For example, FDA’s internal operating procedure for this is that some safety alerts might just be safety alerts and/or market withdrawals (i.e., not necessarily reportable to the FDA).  Accordingly, you should certainly NOT invoke Part 806 just because you’ve issued a safety alert.  Instead, invoke Part 806 when Part 806 says to invoke Part 806.

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That Advisory Notice Might be a Recall

Posted by Kevin Randall In FDA, Recalls 0 comment

March 8, 2023

That Advisory Notice Might be a Recall

 

I received a question today wondering if user facilities should be notified to quarantine devices if a device safety issue is suspected.  The answer is yes, but with great care.  Specifically, if a device safety issue suspected with distributed units, then the manufacturer certainly can advise affected parties, like user facilities, to immediately quarantine the product while an investigation and risk assessment are underway.  But I’ve seen some prominent multinational medical device corporations advise to be VERY careful and aware that such a quarantine instruction and field action could be automatically considered by FDA to be a recall.

 

This seems in part to be because such a quarantine-and-investigate action could meet the “removal” and “inspection” qualifiers in FDA’s recall definition when paired with a scenario where the underlying basis for such an action is consistent with FDA’s triggers/criteria for “recall”.  In other words, FDA can consider firms to have initiated a recall even if the firm doesn’t realize it at the time.

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EU MDR EUDAMED Accuracy Monitoring – Article 31(5)

Posted by Kevin Randall In EU MDR, EUDAMED 0 comment

March 6, 2023

EU MDR EUDAMED Accuracy Monitoring – Article 31(5)

 

I’m unaware of any EUDAMED functionality at this time that accommodates the Article 31(5) accuracy monitoring.  With our clients, we’ve embedded procedures for the periodic accuracy check into a “CE Marking” SOP under Article 10(9), third paragraph, indent (a).  Document the periodic accuracy checks via a controlled form or simply by writing a note to the regulatory file.

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Intended Use vs. Indications For Use: In FDA Submissions and the QMS

Posted by Kevin Randall In 510(k), Indications for Use, Intended Use, Labeling, PMA 0 comment

March 3, 2023

Intended Use vs. Indications For Use: In FDA Submissions and the QMS

 

I’ll forego a baseline explanation of the difference between “Intended Use” as distinguished from “Indications for Use”, as that was covered in a prior blog entry here.

 

In premarket regulatory submissions or in the Quality Management System (QMS), the Intended Use and the Indications for Use definitely need to be stated separately or otherwise clearly distinguished.  I explain further below.

 

For example, in a U.S. FDA 510(k) submission, both the Intended Use (i.e., the general purpose of the device or its function as shown by the labeling) and the Indications for Use (i.e., the disease or condition the device will diagnose, treat, prevent, cure or mitigate, including a description of the patient population for which the device is intended) need to be distinctly established; though perhaps not always obviously so.  Specifically, the Intended Use is linked to, and intrinsically governed/established by the applicable classification regulation (e.g., 21 CFR 8XX.XXXX) that must be stated in the 510(k).  In contrast, the Indication(s) for Use is/are linked more so to the corresponding FDA Product Code (if at all) which must also to be stated in the 510(k), but in any event, distinctly stated by way of the FDA Form 3881 and in the labeling.

 

All this said, in practice, for example regarding for the purposes of 510(k) substantial equivalence, FDA tells us that the Indications for Use are generally encompassed within the Intended Use.  Thus, these distinctions can, in practice, be nebulous.  For example, sometimes the Indications will simply be the same as the Intended Use (see aforesaid blog link) in simple cases where the sponsor has elected not to striate particular indications within the Intended Use; indeed, such granularity isn’t always required.  So in that instance, the reason for combining them is simply that no specific Indications have been devised beyond the general Intended Use.  But oftentimes, specific Indications are indeed distinguished under the overarching general Intended Use, in which case, they need to be clearly stated to meet the intent of a 510(k).

 

Regarding the QMS, the subject device’s intended use principally affects the QMS by way of the corresponding device risk class.  Specifically, that risk class (see the subject device’s classification regulation) dictates the nature and complexity of the QMS and of the QMS documents. For example, certain FDA class I devices are exempt from design controls, while others are exempt from FDA GMP altogether (except for complaint files and records).  I’m a strong proponent that this distinction is essentially required to be stated in the QMS’s Quality Manual.

 

And going deeper down to the level of the Indications for Use and their effect (if any) on the QMS, such effects are often of a more granular nature.  For example, the required type and extent of device developmental documentation will be affected by the indications, such as the need for prospective clinical data regarding some indications, while others only need bench data.  In that context, the targeted indications are to be distinguished in the design inputs (where design controls apply).  Another QMS example is that the indications for use can also have an impact on the nature and extent of post-market surveillance.  Still other QMS examples could be given.

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