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FDA Medical Device Accessory Packaging Requirements
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FDA Medical Device Accessory Packaging Requirements
FDA Medical Device Accessory Packaging Requirements
FDA Medical Device Accessory Packaging Requirements
FDA Medical Device Accessory Packaging Requirements
FDA Medical Device Accessory Packaging Requirements
FDA Medical Device Accessory Packaging Requirements
FDA Medical Device Accessory Packaging Requirements
FDA Medical Device Accessory Packaging Requirements
FDA Medical Device Accessory Packaging Requirements
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fda requirements, medical device accessories, packaging (general), packaging standards and specifications
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  Post Number #9  
Old 22nd February 2018, 05:43 PM
QAengineer13

 
 
Total Posts: 142
Re: FDA Medical Device Accessory Packaging Requirements

Quote:
In Reply to Parent Post by QAengineer13 View Post

Its an interesting point, the FDA Guidance on this is; on your section 4.3 is :

"A.6. Question: Are single-use devices required to bear a UDI?
Generally, a single-use device is required to bear a UDI on its label. One general exception to that requirement is where individual single-use devices all of a single version or model are distributed together in a single device package and intended to be stored in that device package until removed for use. Then the UDI is not required on the device label, but is still required on the device package. This exception is not available for any implantable device.Also, if the devices are intended for individual commercial distribution, the device label and package for these individual devices is required to bear a UDI. 21 CFR 801.30(a)(3) Single use devices are not required to bear a permanent UDI, even if re-processed. 21 CFR 801.45(d)(3)".
The Excerpt above is from https://www.fda.gov/downloads/Medica.../UCM410439.pdf
Thanks to QAengineer13 for your informative Post and/or Attachment!

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  Post Number #10  
Old 22nd February 2018, 05:50 PM
QAengineer13

 
 
Total Posts: 142
Re: FDA Medical Device Accessory Packaging Requirements

Here you go Robet.Beck the guidance is from here https://www.fda.gov/downloads/Medica.../UCM410439.pdf

Regarding the Direct Marking, I would recommend you applying this guidance principle:
https://www.fda.gov/downloads/Medica.../UCM452262.pdf 2

Section C1 and C2 related to Reprocessing, your comment about

" used in situations where the device is used and re-used, and the marking may become separated from the original label and package". so your conclusion is not what the FDA's current thinking is!
  Post Number #11  
Old 22nd February 2018, 09:21 PM
robert.beck

 
 
Total Posts: 50
Re: FDA Medical Device Accessory Packaging Requirements

thanks for this interesting comment. this arose with a package that contains six individual items that are sent to and used by the same patient. each item is single use but not all six are necessarily from the same lot. each item is labeled with its lot. since complete UDIs are not required, is it reasonable to assume that complete, automatic traceability is not required, and it is ok to not track which lots go into each package?
  Post Number #12  
Old 22nd February 2018, 09:22 PM
robert.beck

 
 
Total Posts: 50
Re: FDA Medical Device Accessory Packaging Requirements

I agree with you, based on that guidance document.
  Post Number #13  
Old 22nd February 2018, 10:29 PM
QAengineer13

 
 
Total Posts: 142
Re: FDA Medical Device Accessory Packaging Requirements

Good, I am glad I was able to help.
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