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

 
 
Total Posts: 948
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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