Drawing Requirements for Catalog Items (Class II Medical Device)

Swimming In The Soup

Starting to get Involved
#1
Hi all,

I have been using this board as a resource for a while but this is my first question posed.

I am trying to bring a Class II Medical Device to a 510(k). I asked for the bill of materials and the drawings to create a matrix tracing the BOM to the drawings.
The BOM is filled with part numbers from distributors of catalog items. The drawings I received were closer to assembly drawings but did not include any of the catalog items. A previous company I worked for created drawings down to the screws and such by placing the catalog info on the drawing. The incoming verification was for part number only. I can't find any regulatory advice with my own search so I would like the advice of industry experts.

Do items listed by catalog number need to have a drawing and what information should be captured?

These items include items like pumps and catalytic converters as well as screws, nuts, and bolts.

Thanks in advance.
 
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#2
Sec. 820.50 Purchasing controls.
Each manufacturer shall establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements.
(a) .... Each manufacturer shall:
(1) ....
(2) Define the type and extent of control to be exercised over the product, services, suppliers, contractors, and consultants, based on the evaluation results.
(3) ....
(b) Purchasing data. Each manufacturer shall establish and maintain data that clearly describe or reference the specified requirements, including quality requirements, for purchased or otherwise received product and services. ....Purchasing data shall be approved in accordance with § 820.40.

There is no requirement that there be a drawing for off-the-shelf components. Requirements for the purchased item are typically based on the associated risk.
 

Swimming In The Soup

Starting to get Involved
#3
It's (3)(b) that I am struggling with. The risk is significant for the pumps and other critical items. Even the safety monitoring equipment is off the shelf. Thanks for the input.
 
#4
Options for ensuring your purchased item is compliant to requirements:
  • Review supplier test data for the item purchased
  • Perform incoming inspection of component/assembly - can be a functional assessment
  • Audit the supplier
  • Have a change agreement with the supplier that requires approval and verification of changes prior to implementation
 
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