For a Drug-Device Combination Product, 'Design Control' Process is triggered at?

v9991

Trusted Information Resource
#1
As clarified in the the referenced FDA PPT,"Design Controls"

Design Controls - When to Start?
• Where research ends and design begins
• After Feasibility/“Proof of Concept”
• When you plan to bring your device to market
• Prior to start of any Investigation Device Exemption
(21 CFR 812)
• Premarket
• Mechanism of change/revision
Above statement is pretty self explanatory for an new-product/drug. My query is about interpreting it for an 'GENERIC / ANDA' product;

Because, the feasibility is already established by innovator/NDA_holder; hence, when a generic drug manufacturing starts development, at what stage does the 'design control' start. (typical starting steps are with an prototype, and pilot study)
 
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Ronen E

Problem Solver
Staff member
Moderator
#2
As clarified in the the referenced FDA PPT,"Design Controls"



Above statement is pretty self explanatory for an new-product/drug. My query is about interpreting it for an 'GENERIC / ANDA' product;

Because, the feasibility is already established by innovator/NDA_holder; hence, when a generic drug manufacturing starts development, at what stage does the 'design control' start. (typical starting steps are with an prototype, and pilot study)
A lot of companies do feasibility studies on "me too" devices as well. The fact that it's no longer novel for the original inventor doesn't mean that another org doesn't need a "research phase" before that can wrap their heads around it, and build confidence in technological and economical viability of the endeavour.

On the other hand, if feasibility is much of a no-brainer, and there's a clear intention to go to market with the outcome, I'd say design controls should apply from the get-go.
 
Last edited:

Statistical Steven

Statistician
Staff member
Super Moderator
#3
First design controls are for the DEVICE, not the generic drug. Though the device and generic, each individually have been cleared, your design control studies are about the drug/device combination. So you are looking at bio-compatibility, drug delivery requirements, usability with your drug, etc.



As clarified in the the referenced FDA PPT,"Design Controls"



Above statement is pretty self explanatory for an new-product/drug. My query is about interpreting it for an 'GENERIC / ANDA' product;

Because, the feasibility is already established by innovator/NDA_holder; hence, when a generic drug manufacturing starts development, at what stage does the 'design control' start. (typical starting steps are with an prototype, and pilot study)
 

v9991

Trusted Information Resource
#4
one other question, at what time do we require to have "GMPs" around the 'data' generated at various stages. ( design inputs - outputs etc stages)

is it required to have GMP systems around 'design inputs' stage onwards?
typically for an ANDA product, D-inputs involve reverse engineering from reference product; etc., and they typically get evolved over period of time.

and I believe that design-verification and design-validation certainly require GMPs.

pl. help clarify.
 
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