Hey Ginger,
Great questions/comments. I always appreciate your perspectives and feel your pain. I suggest that the compliance/regulatory department's most important job is to accurately understand, and plan accordingly, for what FDA (by way of U.S. law) thinks and believes. As noted in my first post (and as you reiterated), an importer and manufacturer can collaborate to get a special exemption from FDA for allowing the importer to do the required MDR reporting for both parties.
However, my experience, and FDA apparently is agrees, is that foreign manufacturers and the stateside importer(s) often don't have a close business relationship. For example, time and again I've seen where foreign manufacturers rapidly connect with any number of initial importers to facilitate faster introduction of their products into the U.S. As concerning as that may be, it's reality.
Accordingly, U.S. medical device law and FDA (via its promulgated regulations based on the law) have retained its stance on the separate reporting obligations for importers as distinguished from manufacturers. Here are various statements [emphasis added by me] from FDA when it promulgated its regulations on this matter, and some of them respond to the same concerns Ginger raised:
- "...Who Shall Report...Although manufacturers and importers would be subject to identical reporting requirements...each has been separately defined to clarify that both would be required to report..."
- "...One comment suggests that a distributor be permitted to submit reports on behalf of a manufacturer with the manufacturer's consent...FDA disagrees with the comment. A manufacturer is ultimately responsible for its devices..."
- "...The rule applies equally to manufacturers and importers..."
- "...The final rule applies to all manufacturers and importers of marketed devices..."
- "...The Food and Drug Administration (FDA) is issuing a final rule that requires manufacturers and importers...to report to FDA..."
- "...The [importer complaint file] requirement also is necessary to enable FDA to determine whether...an importer is reporting when it receives or otherwise becomes aware of [reportable] information...Absent the complaint file requirement, FDA could-not be assured that device importers had fully complied with the [importer MDR reporting] requirements of the final rule..."
- "...Many comments on the 1980 proposal recommended that all device distributors [including importers] be exempt from reporting, primarily because manufacturers are more knowledgeable about their devices and are better equipped to evaluate potential device problems and hazards. Other comments stated that FDA would receive unnecessary multiple reports of the same incident if both manufacturers and distributors were required to report...FDA has carefully considered the comments...and has tentatively concluded [that this suggestion has merit] with one exception regarding importers...FDA is retaining...the requirement of the 1980 proposal that device importers report...for two reasons: (1) information concerning deaths or serious injuries and requests for correction involving an imported device will most likely be sent to the importer (as the first link in the chain of domestic distribution of a device), not to the foreign manufacturer; and (2) FDA has no authority to require foreign manufacturers to report device incidents to the agency..."
- "...If FDA is to be able to prevent or reduce deaths or serious injuries from devices...the agency needs to receive this information in a timely manner from all manufacturers and importers..."
In light of the FD&C Act's and FDA's underlying premises for the separate importer and manufacturer MDR requirements, I again strongly assert that it is imperative (to a firm's regulatory health and to public health) that the foreign manufacturer and initial importer clearly understand and distinguish their statutorily separate MDR reporting obligations, and then to approach MDR reporting accordingly. It would be contrary to U.S. law if we were to think that a manufacturer's MDR report unilaterally fulfills the importer's separate MDR reporting obligation, or vice versa. Such collaborative MDR reporting is only permitted by special exemption granted after applying to the FDA and demonstrating therein that the collaboration and parties can fulfill the separate intentions for importer MDR reporting vs. manufacturer MDR reporting.
Because MDR reporting is a robust topic with the potential to precipitate much discussion, I'm going to repost my current narrative in a new thread on importer MDR reporting so that subsequent discussion on that topic can proceed if needed without convoluting Vicki's intended discussion regarding registration and inspection obligations of importers/distributors compared to manufacturer's. See you all there, or here, or both!
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Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2021 by ComplianceAcuity, Inc. All rights reserved.
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Original Message:
Sent: 28-Apr-2021 07:40
From: Ginger Cantor
Subject: FDA Auditing Question
Hi Kevin
Yes, the minimum is that importer reports because the foreign manufacturer can cede all MDR reporting responsibility to the initial importer by contract and formal notification to FDA letting them know they have done that.
However, I would believe that it is good business liability practice for the manufacturer and importer to be in communication about MDRs before they are reported so that assessment can be made by manufacturer based on their risk assessment and experience whether an event is reportable or not and that the correct IMDRF MDR codes are used. And frankly, the manufacturer is doing the investigation. It seems like your wording implies the manufacturer has no authority to review and oversee what the importer is doing. They should in facr.
I am not advocating all reports get squelched but honestly, some companies choose importers that absolutely have no business doing MDR reports, and then really that escalates liability for the company.
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Ginger Cantor, MBA, RAC
Founder/Principal Consultant
Centaur Consulting LLC
River Falls, Wisconsin 54022 USA
715-307-1850
centaurconsultingllc@gmail.com
Original Message:
Sent: 27-Apr-2021 17:12
From: Kevin Randall
Subject: FDA Auditing Question
It's crucial that manufacturer and initial importer clearly understand and distinguish their statutorily-separate MDR reporting obligations. Blending them together without prior authorization from the agency is a recipe for compliance trouble and perhaps even compromised safety; FDA requires these separate MDR reporting obligations because the agency believes they are necessary for public health.
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Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2021 by ComplianceAcuity, Inc. All rights reserved.
Original Message:
Sent: 27-Apr-2021 15:00
From: Vicki Ong
Subject: FDA Auditing Question
Hi Kevin,
From what I know having been here the past 2 years, every time we have a potential MDR from one our customers, we would escalate it to Canon Japan (corp) quality team to evaluate and determine if it truly is an MDR on their end before we here in the U.S. file a MDR. That is my understanding. I've worked in complaints in years past and I have never come across this type of situation. I'm still trying to understand the processes.
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Vicki Ong
Sr. Regulatory Affairs/Quality System Specialist
American Society for Quality
Lake Forest CA
United States
Original Message:
Sent: 27-Apr-2021 14:24
From: Kevin Randall
Subject: FDA Auditing Question
Hi Vicki,
A domestic firm's establishment registration obligations (or lack thereof) are determined by the operations in which it is engaged. If a firm's operations include initial importation plus wholesale distribution (either private label or OEM label), then the firm's initial importation operations are subject to establishment registration and GMP / quality system compliance, while the wholesale distribution operations remain exempt from registration and GMP (except for complaint files).
Presuming that the initial importer truly performs no manufacturing operations (other than initial importation; remember that FDA categorizes initial importation as manufacturing), then I generally recommend that the initial importer quality system address: Management Responsibility (820.20), Quality Audit (820.22), Personnel (820.25), Document Controls (820.40), Nonconforming Product (820.90); Corrective and Preventive Action (820.100); Handling, Storage, and Distribution (part 820, Subpart L); Servicing, where applicable (820.200); Complaint Files (820.198), where applicable (i.e., scaled to align with whether the importer is the manufacturer's "formally designated complaint unit" or instead simply forwards complaints to the manufacturer's complaint unit); Medical Device Reporting (803); Reports of Corrections and Removals (806); and Device Recalls (21 CFR 7).
If the initial importer is the manufacturer's "formally designated complaint unit", then that is a scenario where the initial importer's establishment registration should tick the "Complaint File Establishment". But if the initial importer instead merely forwards complaints to the manufacturer, then that may be a good candidate for not checking the "Complaint File Establishment" box in FURLS (remember that wholesale distributors must keep complaint files and forward them to the manufacturer but aren't required to register for that).
Yet initial importers should be careful not to confuse functioning as the manufacturer's "formally designated complaint unit" with the separate (but related) requirement for initial importers to submit importer MDR reports. The importer MDR reporting requirement is statutorily separate from the manufacturer MDR requirement (though arrangements can be made with the agency for the importer to perform MDR reporting to meet both parties' respective MDR reporting obligation).
Hope this helps.
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Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2021 by ComplianceAcuity, Inc. All rights reserved.
Original Message:
Sent: 27-Apr-2021 13:09
From: Vicki Ong
Subject: FDA Auditing Question
Hi Kevin,
Thank you for your feedback. Much appreciated. We are registered as an Initial Importer (807.40(a)) via FDA registration and as a company that maintains complaint files required by the 21 CFR 820. There was an agreement that we signed with corporate last year stating that we would address all MDR submission here in the states if there should be MDRs that needed to be filed. I have already registered with our new company name for esubmission via Webtrader. We have a production account already in place to be able to submit. In your opinion, FDA can still come in for auditing our processes, but based on how our company is registered thru FDA, they can only audit us on our QSR process and NOT manufacturing related processes? Wanted to clarify.
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Vicki Ong
Sr. Regulatory Affairs/Quality System Specialist
American Society for Quality
Lake Forest CA
United States
Original Message:
Sent: 26-Apr-2021 18:57
From: Kevin Randall
Subject: FDA Auditing Question
Domestic (U.S.) establishments that are true wholesale distributors are exempt from FDA Establishment Registration and Device Listing, as well as from the requirements of 21 CFR Part 820 (except for complaint files, and by default, record keeping).
Foreign establishments that are true wholesale distributors into the U.S., are NOT exempt from FDA Establishment Registration and Device Listing, but remain exempt from 21 CFR Part 820 (except for complaint files, and by default, record keeping).
The authority for the distributor complaint file requirement comes by way of the FD&C (the Act) and is promulgated into regulations in 21 CFR Part 803.
The way FDA is kept apprised of the operations in which a registered establishment is engaged is by the establishment category(s) selected in the FURLS system when doing (or updating) the Establishment Registration. For example, by selecting "Foreign Private Label Distributor" for a foreign wholesaler.
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Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2021 by ComplianceAcuity, Inc. All rights reserved.
Original Message:
Sent: 26-Apr-2021 17:15
From: Vicki Ong
Subject: FDA Auditing Question
Hello RAPs Community Members,
I have a question regarding FDA audits and hoping someone may know something about this.
Background: I work for Canon and last July 2020, our medical division became a new company with a new Canon company name. As a new company, we NO LONGER manufacture any products, only as a distributor. We are still under Canon Corporation in Japan, and manufacturing is all done there.
My Question: As a only distributor company now, when FDA comes in for auditing, how do they know to audit us a distributor and not a manufacturer? Do we need to supply some type of memo to the auditor that we are no longer manufacturer, but a distributor? Does FDA automatically know what type of medical device company we are when they look at our at how we are registered as a company when we had registered our company with FDA?
There was some discussion amongst our team and corporate stating that FDA auditing might not be required since we are only a distributor and not a manufacturer. I am thinking we are still required for FDA audits because they need to see that we are in compliance with QSR per 21 CFR 820. Even though we don't manufacturer, we are still responsible to make sure our processes are in place and in compliance.
Thanks,
Vicki
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Vicki Ong
Sr. Regulatory Affairs/Quality System Specialist
Lake Forest CA
United States
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