Requirements for Contract Manufacturing of a Medical Device

[WilBryan]

Can someone help me locate the requirements for contract manufacturing of a Medical Device?

Our company is a 9001:2015 & 13485:2016 registered engineering and build to print firm. We specialize in capital equipment but have also done end product in low volumes. We have taken an exclusion to 13485 - 7.3 as we do not design or build medical devices. We only carry the certificate to help understand the needs of capital equipment customers who use the automation cells we build to produce medical devices (think 'machine that makes syringes').

Our sales team is consulting with a company who has a 510K on a Class II medical device. They are looking for engineering work to make some minor changes to their device (component size, user interface, etc.).

I want to make sure we do not run afoul of the FDA as we are not currently registered with them.

Ultimate answers (I think) I am looking for...
1. Would we be required to register with the FDA to make design changes to an existing medical device we were not the end manufacturer of?
2. Would we be considered as doing 'design and development' if we are not the company who produces the medical device?

Any help would be appreciated... The body of knowledge and experience here never ceases to amaze me.

 

[yodon]

I'm a bit confused about who the manufacturer of record is. Is that your company or someone else?

The requirements for a (contract) manufacturer are defined in the QSR and 13485. If you (as manufacturer of record) happen to contract manufacturing out then you need to ensure that they comply with the requirements.

If you're talking about FDA registration, as far as I know, only manufacturers need to be registered (don't know of any requirements for design shops to register).

If your ISO scope does not include design services, then you would be running afoul of your own procedures. (And if the company that is hiring you is basing their requirements / approval off your ISO cert then they have not selected correctly since design is not in your scope... if that's the case).

If I misunderstood, my apologies (it's late Friday and has been a loooong week).

 

[Ronen E]

Our sales team is consulting with a company who has a 510K on a Class II medical device. They are looking for engineering work to make some minor changes to their device (component size, user interface, etc.).

I want to make sure we do not run afoul of the FDA as we are not currently registered with them.

Ultimate answers (I think) I am looking for...
1. Would we be required to register with the FDA to make design changes to an existing medical device we were not the end manufacturer of?
2. Would we be considered as doing 'design and development' if we are not the company who produces the medical device?

I’d like some clarification please, concerning the phrase I bolded-up. By “engineering work” and so forth do you mean design only, or physical works to modify already-manufactured devices?

 

[WilBryan]

Depending on the customer both. In the instance at hand now, we are being asked to make design changes that are small and will not require a new 510k

 

[Ronen E]

In the instance at hand now, we are being asked to make design changes that are small and will not require a new 510k

Ultimate answers (I think) I am looking for...
1. Would we be required to register with the FDA to make design changes to an existing medical device we were not the end manufacturer of?
2. Would we be considered as doing 'design and development' if we are not the company who produces the medical device?

I’m only relating to the instance at hand now.

1. In the FDA context you’ll be acting as a supplier, a service provider / a design provider. Suppliers who are not Contract Manufacturers from the FDA perspective (doesn’t matter that you might be from other perspectives) are not required to register with the FDA.

2. From the ISO 13485 angle I would say that yes, you’ll be considered as doing 'design and development', even if you are not the company who produces the medical device, and even if it’s “only” a design change (that does/doesn’t require a 510(k) - not relevant for ISO 13485 considerations).

 

[WilBryan]

We are not the manufacturer of record. The customer is actually using a third party company who specializes in very low volume medical device design. They will be the Manufacturer. We would be acting only as a design house.

If we are not designing the end product, only reducing size elements etc. it still qualifies as a medical device? I figured as much. SO, clear with the FDA but ISO world we are designing and shouldn't take the exception.

Does anyone have a section or page reference for the definition of Contract Manufacturer per the FDA? I've been through the fda.gov site and haven't seen any clear indication of what they consider as contract manufacturing.

thanks everyone for the help and advice!

 

[Ronen E]

We are not the manufacturer of record. The customer is actually using a third party company who specializes in very low volume medical device design. They will be the Manufacturer. We would be acting only as a design house.

That is understood, and doesn’t change my previous opinions.

If we are not designing the end product, only reducing size elements etc. it still qualifies as a medical device?

It used to (officially) matter with ISO 13485:2003, which was created with only finished devices manufacturers in mind (practically in recent years it was used by many other types of orgs and certifying bodies kinda went with the flow and allowed it). Anyway, the 2016 revision was intentionally adjusted to suit any and all kinds of entities along the medical devices supply chain, so the question of whether you’re dealing with the actual finished device (or finished device design) is less relevant now. As long as you’re modifying some of the medical device design, you’re involved in design & development for ISO 13485:2016 purposes.

Does anyone have a section or page reference for the definition of Contract Manufacturer per the FDA? I've been through the fda.gov site and haven't seen any clear indication of what they consider as contract manufacturing.

The definition I’m used to working with is in this page, reproduced below:

Contract Manufacturer - Manufactures a finished device to another establishment's specifications.

(I added the emphasis)