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Class II Medical Device 510(k) Purchase - Documentation Transfer Requirements

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Related Topic Tags
510(k), class ii medical device, fda (food and drug administration), fda requirements, medical device company or industry
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  #1  
Old 5th March 2012, 11:19 AM
ascherp

 
 
Posts: 56
Please Help! Class II Medical Device 510(k) Purchase - Documentation Transfer Requirements

Hello,

Purchasing all rights for manufacture of a medical device involves the transfer of many documents to the new owner. The medical device in question is a Class II device that is sold worldwide and that has been cleared by a 510(k).

I am concerned about the documents that the new owner needs to request from the original 510(k) owner to cover all FDA requirements should the firm ever be inspected and have come up with the following list:

1) DMF, DHF
2) DMR, DHR
3) 510(k) submission file
4) Customer complaints and followup
5) Nonconformances / CAPAs
6) Any design / labeling / material etc. changes post 510(k) clearance date, including rationale for not submitting a new 510(k)
7) MDR events
8) Manufacturing processes, work instructions etc.
9) List of suppliers and incoming product testing instructions
10) Sterilization and packaging validations / supplier lists (for single use components)
11) Biocompatibility test results
12) Validation reports of end user processing instructions (for reusable components)
13) Performance testing protocols and results

Am I missing anything? I'd appreciate your opinion(s)!

Best regards

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  #2  
Old 6th March 2012, 02:05 AM
Stijloor's Avatar
Stijloor

 
 
Posts: 14,654
Re: Class II Medical Device 510(k) Purchase - Documentation Transfer Requirements

A Quick Bump!

Can someone help?

Thank you very much!!

Stijloor.
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  #3  
Old 7th March 2012, 12:48 AM
bio_subbu's Avatar
bio_subbu

 
 
Posts: 596
Re: Class II Medical Device 510(k) Purchase - Documentation Transfer Requirements

Quote:
In Reply to Parent Post by ascherp View Post

Hello,

Purchasing all rights for manufacture of a medical device involves the transfer of many documents to the new owner. The medical device in question is a Class II device that is sold worldwide and that has been cleared by a 510(k).

I am concerned about the documents that the new owner needs to request from the original 510(k) owner to cover all FDA requirements should the firm ever be inspected and have come up with the following list:

1) DMF, DHF
2) DMR, DHR
3) 510(k) submission file
4) Customer complaints and followup
5) Nonconformances / CAPAs
6) Any design / labeling / material etc. changes post 510(k) clearance date, including rationale for not submitting a new 510(k)
7) MDR events
8) Manufacturing processes, work instructions etc.
9) List of suppliers and incoming product testing instructions
10) Sterilization and packaging validations / supplier lists (for single use components)
11) Biocompatibility test results
12) Validation reports of end user processing instructions (for reusable components)
13) Performance testing protocols and results

Am I missing anything? I'd appreciate your opinion(s)!

Best regards
The documentation you need will depend on the device for which you bought the 510(k). Some items in your list may be incorporated in some of the files you listed. For example, “Any design / labeling / material etc. changes post 510(k) clearance date, including rationale for not submitting a new 510(k)” would be part of the Design History File (DHF).
Thanks to bio_subbu for your informative Post and/or Attachment!
  #4  
Old 2nd July 2013, 11:28 AM
clarked3

 
 
Posts: 7
Please Help! Re: Class II Medical Device 510(k) Purchase - Documentation Transfer Requirements

I have a question relating to this topic that I'm hoping someone could help me with.

The company I work for have done a similar acquisition of a Class III medical device. We are in the middle of a Technology Transfer with a submission upcoming in the next few months.

My question is as follows: How should the original design history documentation be absorbed by my company?

We are basically repeating everything from the Validation onwards as the manufacturing process has moved to a new facility. The User Requirements still stand, as well as the Design Inputs and the majority of the Verification but we have had to revalidate the entire process. Because of this all the validation work has new document references and so do all the Design Output documents.

What I'm unsure of is what happens to the original validation and output documents? The way I see it, if we don't absorb the documentation in some way, then effectively the design history and all the learnings from the validation work is lost. We cannot put the other company's original documents into our Quality System. What I want to do is put them into the DHF exactly the same as how the original company would have created it, freeze the DHF and then document the re-validation through the change control process.

The alternative is to update the original documentation with our new references. i.e. a new Input Output Verification Validation matrix and new design output document and put copies of the new validation documents in the DHF as a new revision to the originals?

Any help would be greeatly appreciated!

Thanks
  #5  
Old 2nd July 2013, 04:59 PM
markl368

 
 
Posts: 22
Re: Class II Medical Device 510(k) Purchase - Documentation Transfer Requirements

At some point I would think you would want to have a formal review of the previous company's DHF and document your approval of its completeness and suitability for transfer within your company. In that case, you may be able to set up a review document with your company's specific format, definitions, references, etc. and then append the previous DHF as an attachment and keep that within your quality system documentation. Any "gaps" or risks found during the review would then be addressed with actions, such as the process validation you've noted. And it may include some need to transcribe documents from the previous owner if you find gaps or if you feel there is a risk inherent in using the previous documents.

Then complete the necessary actions to fill the gaps and mitigate the risks...of course if you reach a conclusion that some re-design is needed, that may require a new 510K submission! But you should then have a complete and effective DHF transferred to your manufacturing unit!
Thanks to markl368 for your informative Post and/or Attachment!
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