OEM Supplier of Accessories Registration and 21 CFR 820 QSR Controls Applicability

sreenu927

Quite Involved in Discussions
#1
Hi

I seek clarification on establishment registration and appropriate QSR controls for OEM Suppliers.

Case 1): Company A owns the design of product(P1); company B manufactures P1 and packs and sends to A. This P1 is the finished good that is an accessory to an IVD medical device P.
P+P1 form as a system and will be sold to customers.

Case 2): Company A owns the product system (P+P1)-legal manufacturer; Company B owns the design and also manufactures P1 and packs and sends to A. This P1 is the finished good that is an accessory to an IVD medical device P.

For both cases 1) and 2), for the below options what are the Establishment registration and OEM supplier applicable QSR controls:

i) P is a class II IVD device; then if we submit a 510(k), it will be for P&P1, where P1 also falls under Class II and B need to implement the QSR Controls similar to that level of P - in the sense, fully comply with 21 CFR 820 - is this correct?

So in this case, does B has to register with FDA and need to fully comply with 21CFR 820?

ii) P1 is an accessory (not re-orderable), and labeled as "General Purpose Laboratory Equipment", then does B
- requires registration with FDA?
- need to comply fully or partially with 21 CFR 820?

iii) if P1 is customer reorderable (consumable), and if A labels it with an IVD symbol in it, then does B
- need to register with FDA?
- need to comply fully with 21 CFR 820 or only with complaint files and quality records?

iv) if P1 is customer reorderable and labeled as "General Purpose Reagent" or "General Purpose Laboratory Equipment" then, does B
- requires registration with US FDA?
- need to comply fully with 21 CFR 820 or only to 820.198 complaint files and 820.180 records?

For 4 options, the 510(k) will be submitted for P that includes P1 as well. No intend to submit a separate 510(k) for P1.

The other thing is if we don;t have a separate 510(k) for P1, then can it be sold as reorderable accessory/consumable?

Thanks,
Sreenu
 
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sreenu927

Quite Involved in Discussions
#2
Re: OEM Supplier of Accessories Registration and 21 CFR 820 QSR Controls Applicabilit

Appreciate any response!

Thanks,
Sreenu
 

Ronen E

Problem Solver
Staff member
Moderator
#3
Re: OEM Supplier of Accessories Registration and 21 CFR 820 QSR Controls Applicabilit

In a nutshell: All contract manufacturers are now required to register and list. The QSR is directly applicable to legal manufacturers only (requirements may be contractually extended to contract manufacturers by legal manufacturers).

Cheers,
Ronen.
 

sreenu927

Quite Involved in Discussions
#4
Re: OEM Supplier of Accessories Registration and 21 CFR 820 QSR Controls Applicabilit

Many Thanks Ronen!

Another case:

Mfg(M) buy finished goods (say halogen lamps) for use in instruments from Supplier(S).

Labeled at M as IVD and M has all controls in place (registered with FDA, ISO
13485), then does S needs to be registered with US FDA, as per the new regulations?

Thanks,
Sreenu
 

Ronen E

Problem Solver
Staff member
Moderator
#5
Re: OEM Supplier of Accessories Registration and 21 CFR 820 QSR Controls Applicabilit

Many Thanks Ronen!

Another case:

Mfg(M) buy finished goods (say halogen lamps) for use in instruments from Supplier(S).

Labeled at M as IVD and M has all controls in place (registered with FDA, ISO
13485), then does S needs to be registered with US FDA, as per the new regulations?

Thanks,
Sreenu
S has to register and list only if it manufactures medical devices under contract. If these are commodity halogen lamps then it seems S is a component supplier but not a contract manufacturer under the regulation.
 

sreenu927

Quite Involved in Discussions
#6
Re: OEM Supplier of Accessories Registration and 21 CFR 820 QSR Controls Applicabilit

Thanks again Ronen..further more, if this lamp is reorderable, then also can we consider S as Component Supplier or a Contract mfg?

And to clarify, reorderable from us, not from S!

Thanks,
Sreenu
 

Ronen E

Problem Solver
Staff member
Moderator
#7
Re: OEM Supplier of Accessories Registration and 21 CFR 820 QSR Controls Applicabilit

Thanks again Ronen..further more, if this lamp is reorderable, then also can we consider S as Component Supplier or a Contract mfg?

And to clarify, reorderable from us, not from S!

Thanks,
Sreenu
I don't think it changes the regulatory situation.

Cheers,
Ronen.
 
I

isotsadmin

#8
Re: OEM Supplier of Accessories Registration and 21 CFR 820 QSR Controls Applicabilit

Hi,

Though this is not in relation to any response, I want to pose another question relating to my company.

Our company is certified to TS 16949:2009 and a customer requested for a quote for design and manufacture of medical seats ( used by a doctor who operates a surgery). I reviewed 21 CFR 820.30 and found similar requirements to TS 7.3. My questions are as follows:
1. How does seats of this kind classified under FDA product classification?
2. What level of FDA certification does my need to acquire?
3. Do we need a 501K submission for these seats?
3. Does our company required to be ISO 13485 certified?

Appreciate your response.
 
Q

QA-Man

#9
Re: OEM Supplier of Accessories Registration and 21 CFR 820 QSR Controls Applicabilit

1. How does seats of this kind classified under FDA product classification?
Most chairs are class 1 devices but there are three that are class 2. Do a search here - type "chair" in the "Device" box.

2. What level of FDA certification does my need to acquire?
Your company must register and list. Registration fees are about $3400. You can find out more here. You also required to have a Quality System, the requirements are here. Not having a Quality System won't stop you though. Shouldn't be much of an issue for you seeing as you're 16949 registered and it is all very similar.

3. Do we need a 501K submission for these seats?
Find the description and intended use that matches your chair using number 1 above and it will tell you. Don't go by class - a class 1 dental chair with operative unit requires one but a class 2 electric positioning chair doesn't.

3. Does our company required to be ISO 13485 certified?
Not unless you plan to export to certain regions such as Europe or Canada.
 

Ronen E

Problem Solver
Staff member
Moderator
#10
Re: OEM Supplier of Accessories Registration and 21 CFR 820 QSR Controls Applicabilit

The answers provided above are mostly correct.

2. What level of FDA certification does my need to acquire?
Strictly speaking, there is no "FDA certification" as such, for class I / II devices. The closest thing to a certification is the 510(k) process, where it applies. Of course, when you register, list and pay the fees you receive confirmations, but it doesn't involve any kind of audit.

More generally, you need to comply with the General Controls, and for class II devices with the Special Controls too (if there are any for the specific ProCode). A QMS (not just any, but one that complies with 21 CFR 820) is a General Control, however some ProCodes are exempt. Once you've done the search for "chair", when you click on any entry you will be redirected to its ProCode page. If it says "Yes" against "GMP exempt", that code is exempt from the QMS requirement. That page also tells you, several lines up, whether or not a 510(k) submission is required for that particular code.

I agree that if the QMS requirement applies you probably won't have a lot of work adjusting your already-certified one; however, it most likely won't automatically be in compliance with part 820. Careful examination and potential gap closing are required. Please note that there is no upfront process of the FDA examining your QMS for compliance. It is a legal requirement and you must be in compliance by the time you start distribution in the USA, though. The FDA might, nevertheless, pay a visit and inspect your compliance (overall, not just the QMS) according to its own priorities and schedule. If you're USA-based this is likely to happen within 2 years from initial registration (excluding for-cause inspections, that may occur immediately if something goes very wrong). If you are located off-shore, you might have a longer grace period.

Cheers,
Ronen.
 
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