Regulatory Open Forum

Hi All,

What is in the scope of design verification regarding to packaging and labeling of medical devices prior to its design validation. What I mean is what is that necessarily should be covered in design verification prior to starting of design validation of packaging and labeling for a medical device. Any guidance document to define the scope of design verification or design validation regard to packaging and labeling.

Regards,
Jayaram

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Jayaram Abimanyu
Chennai
India
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Hi Jayaram

I don't know any rule that says you have to do verification before validation - only a rule that you have to complete both. From a practical perspective, though, I would do verification before validation. Validation exercises tend to be more expensive and time-consuming, so it's more efficient to make sure your packaging and/or labeling samples are correct before going to the trouble of finding out whether they serve their intended purposes.

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Anne LeBlanc
United States
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Original Message:
Sent: 20-Apr-2022 08:38
From: Jayaram Abimanyu
Subject: Packaging and Labeling for Medical Devices: Scope of Design verification and validation

Hi All,

What is in the scope of design verification regarding to packaging and labeling of medical devices prior to its design validation. What I mean is what is that necessarily should be covered in design verification prior to starting of design validation of packaging and labeling for a medical device. Any guidance document to define the scope of design verification or design validation regard to packaging and labeling.

Regards,
Jayaram

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Jayaram Abimanyu
Chennai
India
------------------------------

Hello Jayaram,
Please refer to the paper:
Medical Device Product
Verification and Validation, 
John E. Lincoln. He was a principal of J.E. Lincoln and Associates (www.jelincoln.com), a global consulting
company with more than 29 years experience serving US FDA-regulated industries. The paper explains the process.
I am myself working in device manufacturing.  The verification process 
preceeds validation.  This paper will explain why. Labeling started to get drafted at the verification stage and continuous through the validation and life-cycle of the product . However , when device goes to the stage of clinical testing, the labeling process should be completed, because we use the latest version of the device for the clinical trial ( it calls "production equivalent").
Later on,  any changes in labeling may be not acceptable or acceptable through the additional validation and regulatory approval only.

Hope , it helps.

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Yana Dutt-Singkh
Dr
Mountain View CA
United States
------------------------------

Original Message:
Sent: 20-Apr-2022 08:38
From: Jayaram Abimanyu
Subject: Packaging and Labeling for Medical Devices: Scope of Design verification and validation

Hi All,

What is in the scope of design verification regarding to packaging and labeling of medical devices prior to its design validation. What I mean is what is that necessarily should be covered in design verification prior to starting of design validation of packaging and labeling for a medical device. Any guidance document to define the scope of design verification or design validation regard to packaging and labeling.

Regards,
Jayaram

------------------------------
Jayaram Abimanyu
Chennai
India
------------------------------

Hello Jayaram,
Attached is the FDA presentation that may be helpful to understand the process.
In addition, it would be really helpful to work with Quality Affairs function. They're in charge of data about labeling requirements in the production process:)
Thanks,
Yana

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Yana Dutt-Singkh
Dr
Mountain View CA
United States
------------------------------

Original Message:
Sent: 20-Apr-2022 08:38
From: Jayaram Abimanyu
Subject: Packaging and Labeling for Medical Devices: Scope of Design verification and validation

Hi All,

What is in the scope of design verification regarding to packaging and labeling of medical devices prior to its design validation. What I mean is what is that necessarily should be covered in design verification prior to starting of design validation of packaging and labeling for a medical device. Any guidance document to define the scope of design verification or design validation regard to packaging and labeling.

Regards,
Jayaram

------------------------------
Jayaram Abimanyu
Chennai
India
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