Are we the Specification Developer?

[SGquality]

I have a question on Specification developer - as per the below definition from FDA, would be the Specification developer if we are a contracting firm and develop the specifications for the customers ?

Specification Developer - Develops specifications for a device that is distributed under the establishment's own name but performs no manufacturing. This includes establishments that, in addition to developing specifications, also arrange for the manufacturing of devices labeled with another establishment?s name by a contract manufacturer.

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In my case, the developing of specifications is a contracted activity where we design the product and hand over to the customer and they will be responsible for the 510(K) submission too.

 

[MIREGMGR]

No, you are not. Contract engineering work related to specification development is the same as contract manufacturing work. Regulatory responsibility lies entirely with the company that will be responsible for the product's marketing, and in your example will hold the 510(k).

So, they will be the Specification Developer, even though they have contracted out the actual work.

 

[SGquality]

No, you are not. Contract engineering work related to specification development is the same as contract manufacturing work. Regulatory responsibility lies entirely with the company that will be responsible for the product's marketing, and in your example will hold the 510(k).

So, they will be the Specification Developer, even though they have contracted out the actual work.

In this case, do we have to proceed with FDA Establishment Registration for Contract Manufacturer then ?

 

[MIREGMGR]

That depends on whether you perform manufacturing / realization activities. If yes, then you are a contract manufacturer. If no, then you may be a specification consultant.

 

[SGquality]

Any thoughts on the level of QMS for a "specification Consultant" ?

Which are the applicable clauses of 21 CFR Part 820 ? Is the full blown 820 required ?

 

[MIREGMGR]

You apply the sections that pertain to activities you do.

Typically a specification developer consultant will need at least design control, document control, and records; and possibly CAPA, design aspects of labeling/packaging, and statistical techniques.

 

[SGquality]

You apply the sections that pertain to activities you do.

Typically a specification developer consultant will need at least design control, document control, and records; and possibly CAPA, design aspects of labeling/packaging, and statistical techniques.

Is there any recommended guideline / standard on which sections will apply ?

This morning, we had an internal discussion and the thinking was documentation controls, management controls and your suggested topics may be also required ... so it would mean the entire QMS.

Trying hard to decide which sections may apply

 

[MIREGMGR]

Is there any recommended guideline / standard on which sections will apply ?

No, it's just based on logic...what you do applies, what you don't do doesn't.

 

[SGquality]

Thanks again, MIREGMGR

 

[shimonv]

Hi,
Normally there should be a quality agreement between you and the owner/legal manufacturer, and in it the QMS requirements from you.
The legal manufacture has the overall responsibly and they are the ones who should try hard to decide which sections apply.