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


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21 cfr part 812 - investigational device exemptions, combination drug-device products, design control
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  Post Number #1  
Old 12th August 2017, 05:20 AM
v9991

 
 
Total Posts: 952
Question For a Drug-Device Combination Product, 'Design Control' Process is triggered at?

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

Quote:
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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  Post Number #2  
Old 28th August 2017, 09:33 PM
Ronen E

 
 
Total Posts: 3,526
Re: For a Drug-Device Combination Product, 'Design Control' Process is triggered at?

Quote:
In Reply to Parent Post by v9991 View Post

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 by Ronen E; 29th August 2017 at 02:24 AM.
Thanks to Ronen E for your informative Post and/or Attachment!
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  Post Number #3  
Old 5th September 2017, 09:30 AM
Statistical Steven's Avatar
Statistical Steven

 
 
Total Posts: 1,092
Re: For a Drug-Device Combination Product, 'Design Control' Process is triggered at?

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.



Quote:
In Reply to Parent Post by v9991 View Post

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)
Thanks to Statistical Steven for your informative Post and/or Attachment!
  Post Number #4  
Old 25th September 2017, 11:26 AM
v9991

 
 
Total Posts: 952
Question Re: For a Drug-Device Combination Product, 'Design Control' Process is triggered at?

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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