Package Inserts for Single Packed Implantable

austin_howell

Starting to get Involved
So we have a class II device with the following framework:
  • Individual packaged sterile implant
  • All implants are designated as single use devices
  • Packaging of the implant is a fairly small tube, about the size of a white board marker (~20mm in diameter and 120mm in length)
  • Labels that are provided on the packaging are 1in x 2in in size
  • We have already packed in quite a lot of information on our label with the proper symbols, device information, and company information. If we cut down the size of the information any more I believe we start to verge on information being un-discernable.
So my question is, how do we effectively proved a "Package Insert" to the end user (nuero- and orthopedic surgeons in this case)?

In my past projects device were typically delivered in some sort of box where we could have a paper insert provided, but with the compact size of this device there is not a way to effectively do that. Inside the "tube" is a protective TPU film and the implant so I would not prefer to try and fit it in there.

My intuition is that they could be provided in bulk with the box of implants is shipped during distribution, but I'm unsure if this would receive heavy criticism for an FDA reviewer?

From experience and imagination, I can't help but believe 99.9% of surgeon never look at the packaged insert.
 
In my past projects device were typically delivered in some sort of box where we could have a paper insert provided, but with the compact size of this device there is not a way to effectively do that.
Can you clarify why this isn't possible? I'm pretty sure you will have to provide and IFU for each implant. Can you use onion paper?
 

austin_howell

Starting to get Involved
It is due to the packaging limitations;
1. We cannot include the IFU on paper inside of the tube as the packaging design has already be validated as is with the implant. If we added the IFU in addition to that implant in the tube then we would need to rationalize exempting packaging testing or re-test. Neither of those are great options from a business perspective.
2. Adding paper inside of the tube with the implant will introduce a new bioburden, and testing for this is in currently in process.
3. The label provided on the packaging is small and therefore cannot possible contain all of the IFU information, just warning and essential symbology.

I believe the solution we have settled on is provided a URL address on the label where users can access the IFU. Validating the website on various devices and browsers will be required, but overall the effort should be managable. This also give the company flexibility for as updates to the IFU happen in the future. We considered a QR code but the validation for that is more significant as different phones have different cameras and different operating systems. Not mentioned different lighting and quality of images that can be retrieved.
 
I would never suggest that you place paper with an implant. This introduces issues with particulate, bioburden, and biocompatibility. I suggest you not do this. I was envisioning a small box that the tube goes inside along with the IFU or an IFU taped to the outside of the tube.

Electronic IFU could work. I suggest you discuss this with FDA in a presub meeting.

Also read this: Section 206 of the Medical Device User Fee and Modernization Act (MDUFMA) (New section 502(f) of the Federal Food, Drug, and Cosmetic Act) Electronic Labeling for Prescription Devices Intended for Use in Health Care Facilities - #G03-1 | FDA
 
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