Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

I'm trying to determine if my company is a specification developer based on FDA's definition: 

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.

We provide general input on product development to another party for manufacture, but product realization is done by the manufacturer (they maintain DMR/DHF/DHR, testing, register, etc). We do not specify how to design, test, or manufacture product. 

To what extent does FDA mean by "develops specifications"? 

Are we a Specification Developer? If so, what are the impacts aside from maintaining records DMR/DHF/DHR? Would registering as a spec developer trigger an FDA audit within 6 months similar to what is done for manufacturers?

Thank you!

Dear Anon,

You state you "general input on product development to another party for manufacture, but product realization is done by the manufacturer (they maintain DMR/DHF/DHR, testing, register, etc). We do not specify how to design, test, or manufacture product."  In my opinion, this makes you NOT a specification developer.  It sounds like your firm is more of a market research type company.  However, if your company issues purchase orders to the other party, that could change your status to a specification developer who happens to contract out the actual design and/or manufacturing work.

------------------------------
James Bonds
Director Regulatory Affairs
Atlanta GA
United States
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Original Message:
Sent: 06-Nov-2018 11:46
From: Anonymous Member
Subject: Are we a Specification Developer? (FDA)

This message was posted by a user wishing to remain anonymous

I'm trying to determine if my company is a specification developer based on FDA's definition:

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.

We provide general input on product development to another party for manufacture, but product realization is done by the manufacturer (they maintain DMR/DHF/DHR, testing, register, etc). We do not specify how to design, test, or manufacture product.

To what extent does FDA mean by "develops specifications"?

Are we a Specification Developer? If so, what are the impacts aside from maintaining records DMR/DHF/DHR? Would registering as a spec developer trigger an FDA audit within 6 months similar to what is done for manufacturers?

Thank you!

This message was posted by a user wishing to remain anonymous

Thank you both! Your answers are much appreciated. 

I did a little more digging on "specification consultant" and also followed up with FDA. This was their response:

"The specification developer owns the product and developed the specifications for the device that is being manufactured by another company.  Based on the information provided, I believe the manufacturer developed the specifications for the product and is manufacturing the product.  It sounds like your company is a specification consultant since you are providing general input on product development and does not own the actual product or the specifications for the device.  Your company would be considered a specification consultant.  Specification consultants are not required to register or list with CDRH."

Original Message:
Sent: 07-Nov-2018 06:51
From: James Bonds
Subject: Are we a Specification Developer? (FDA)

Dear Anon,

You state you "general input on product development to another party for manufacture, but product realization is done by the manufacturer (they maintain DMR/DHF/DHR, testing, register, etc). We do not specify how to design, test, or manufacture product."  In my opinion, this makes you NOT a specification developer.  It sounds like your firm is more of a market research type company.  However, if your company issues purchase orders to the other party, that could change your status to a specification developer who happens to contract out the actual design and/or manufacturing work.

------------------------------
James Bonds
Director Regulatory Affairs
Atlanta GA
United States

Original Message:
Sent: 06-Nov-2018 11:46
From: Anonymous Member
Subject: Are we a Specification Developer? (FDA)

This message was posted by a user wishing to remain anonymous

I'm trying to determine if my company is a specification developer based on FDA's definition:

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.

We provide general input on product development to another party for manufacture, but product realization is done by the manufacturer (they maintain DMR/DHF/DHR, testing, register, etc). We do not specify how to design, test, or manufacture product.

To what extent does FDA mean by "develops specifications"?

Are we a Specification Developer? If so, what are the impacts aside from maintaining records DMR/DHF/DHR? Would registering as a spec developer trigger an FDA audit within 6 months similar to what is done for manufacturers?

Thank you!

I second John's answer. Based on the information provided, you probably fit under the category of a "Specification Consultant" or "Market Researcher" as James stated. A specification developer is purely focused on the Design & Development (R&D) activities/ portion of the product lifecycle who may also arrange for its manufacturing.

------------------------------
Phani Puppala
Franklin MA
United States
------------------------------

Original Message:
Sent: 06-Nov-2018 11:46
From: Anonymous Member
Subject: Are we a Specification Developer? (FDA)

This message was posted by a user wishing to remain anonymous

I'm trying to determine if my company is a specification developer based on FDA's definition:

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.

We provide general input on product development to another party for manufacture, but product realization is done by the manufacturer (they maintain DMR/DHF/DHR, testing, register, etc). We do not specify how to design, test, or manufacture product.

To what extent does FDA mean by "develops specifications"?

Are we a Specification Developer? If so, what are the impacts aside from maintaining records DMR/DHF/DHR? Would registering as a spec developer trigger an FDA audit within 6 months similar to what is done for manufacturers?

Thank you!