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FDA Design and Development Planning Requirements

T

Turquoise202

#1
Hi, I have a question regarding two of FDA's design and development planning requirements.

FDA lists the elements that would be typically addressed in the design and development plan, and ends the list with the following:

· Controls for design documentation
· Notification activities.

I assume that controls for design documentation is simply providing information on how the company plans to control the design documents, such as revision history, coding/numbering system and signed approvals?

I can't really understand what "notification activities" refer to. Would really love your help here.

Thanks in advance!
 
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Mark Meer

Trusted Information Resource
#2
Hi Turqoise202,

Can you cite where you're getting these planning requirements?

This sub-forum is for 21 CFR Part 820, and the only reference to design planning I can see in it is 820.30(b):

(b) Design and development planning. Each manufacturer shall establish and maintain plans that describe or reference the design and development activities and define responsibility for implementation. The plans shall identify and describe the interfaces with different groups or activities that provide, or result in, input to the design and development process. The plans shall be reviewed, updated, and approved as design and development evolves.
Otherwise, "notification" typically refers to communication channels that are triggered in certain events. For example "notification" to regulatory authorities when there is a significant change, or "notification" to responsible personnel when a non-conformity is identified.

MM
 

Marcelo

Inactive Registered Visitor
#3
Can you cite where you're getting these planning requirements?
It's from the Design Control Guidance.

I assume that controls for design documentation is simply providing information on how the company plans to control the design documents, such as revision history, coding/numbering system and signed approvals?
Yes.

I can't really understand what "notification activities" refer to. Would really love your help here.
If your design team is composed of different groups or sources, for example (as mentioned in the guidance and in the requirements), you need to define communication, including notification, requirements.
 
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