I thought about my answer and have a different way to explain it. The key is to identify the company that distributes the device under its own name.
In your case there would be only one, none of the other nine perform this role. Call it Company A.
Does Company A manufacture the finished device?
If yes, Company A registers and lists as a manufacturer
If no, Company A registers and lists as a specification developer.
Somebody must make the device, and if Company A doesn’t they must find a company that does. Call them Company J.
In order to manufacture the device, Company J must have a set of specifications. These come from the specification developer, Company A.
Company J is a contractor that provides product to Company A, so must be managed under 820.50.
Company J also has a relationship with FDA, and must register as a contract manufacturer, list, implement QSR, and implement MDR.
Company A also has a relationship with FDA, and must register as a specification developer, list, implement QSR, and implement MDR.
The other nine companies do not have a relationship with FDA, in this scenario. However, they are service suppliers to Company A and come under Company A’s supplier management program in 820.50.
The next question is why must Company J implement MDRs. In particular, is it really a requirement especially after the switch to eMDR on August 14? I’m happy to explain if you don’t know. This should be a criterion for supplier selection.
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Dan O'Leary
Swanzey NH
United States
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Original Message:
Sent: 08-23-2015 15:09
From: Dan O'Leary
Subject: Device Establishment Registration - Specification Developers
The key to the specification developer role is who holds the 510(k). In your case, only one site. From the definition it is the company that “distributes the device under its own name”.
A choice you offered is “One, because the project is under the full control of the lead site and its QMS.” I agree that this one site is the specification developer as long it is the site the markets the device.
Under 820.1(a)(1), that site can tailor QSR for the role. The relevant sentence is “If a [firm] engages in only some operations subject to the requirements in this part, and not in others, that [firm] need only comply with those requirements applicable to the operations in which it is engaged.” One there other side, there is a contract manufacturer making a finished device who must also register, list, and implement QSR.
Now, I’ll address a question you didn’t ask. You said, “Company X, a firm with ten sites, undertakes the development of a new device. The company does not plan to manufacture the device itself. All ten sites are under the corporate umbrella (no contractors or consultants). All ten sites participate in the project.”
As above, one of the ten sites is the lead, has responsibility for the design, and registers as a specification developer. The other nine sites are suppliers to the lead site and must be evaluated, selected, and managed under 820.50. From the FDA position, the corporate relationship is not relevant. The assumption, and rule of thumb, is that each of the nine sites has a QMS that is independent of the lead site. In terms of 820.50 each site is a supplier that provides a service. (Unfortunately, QSR does not define the terms suppliers, contractors, and consultants.)
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Dan O'Leary
Swanzey NH
United States
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Original Message:
Sent: 08-23-2015 13:06
From: David Ledwig
Subject: Device Establishment Registration - Specification Developers
David, Dan and Julie,
Thank you for your comments. I believe I understand the regulatory definition of Specification Developer. I think I can apply the definition to the related activities. The two roles included in the definition: 1) the development of specifications, and 2) arranging for the manufacturing by a contract manufacturer are reasonably straightforward.
But my establishment registration question is related to both activities and geography. Let me propose a hypothetical but common situation:
Company X, a firm with ten sites, undertakes the development of a new device. The company does not plan to manufacture the device itself. All ten sites are under the corporate umbrella (no contractors or consultants). All ten sites participate in the project.
- One site is the project lead. It has final authority over the project. It prepares schedules and plans, authorizes specifications and reviews and approves verification and validation plans and results.
- Four other sites participate by designing components.
- The five remaining sites participate by preparing and executing verification and validation activities (which may contribute to revisions of specifications).
So my question is: How many of these sites should be registered with FDA as specification developers?
- One, because the project is under the full control of the lead site and its QMS. (We might use the term "design authority" to describe the lead site, though the term is not used in the regulation).
- Five (1 + 4), because these sites are all developing specifications.
- All ten, because all sites have influence over the specifications.
My experience is that it is most common that the "design authority" is the single registered establishment. Absent guidance from the agency, my admittedly strict interpretation is that all ten sites are obligated to register. I would welcome any further shared insight or experience.
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[David] [Ledwig] [RAC]
[Principal Consultant]
[Practical Complliance, LLC]
[Brevard] [NC]
[USA]
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Original Message:
Sent: 08-22-2015 12:51
From: David Lim
Subject: Device Establishment Registration - Specification Developers
David,
As for your statements "It may be that this issue is complicated by our modern ways of working today, with many technical professionals widely dispersed; often working remotely with no established place of business. I find it difficult to believe FDA really expects a proliferation of establishment registrations from minor participants scattered around the globe."
As far as ER is concerned, it is straightforward as follows.
1. whether it is a business entity (not individual consultant level)
2. what the entity intends to do (e.g., activity/action), prospectively speaking (except outsourcing compounding facility, which includes some period of retrospective activity)
3. choose all categories it applies (as a manufacturer, CMO, AND/OR specification developer, etc.)
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
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