I need help regarding product responsibility in relationship to FDA

G

Gert Sorensen

#1
Hi there,

Now it's my turn to turn to the cove for guidance.

We manufacture medical devices and sell them to our sister company in the US. They use the products for kits, pack, sterilize and sell them. We, however, hold the FDA registration of the products.

Whose responsibility, under FDA regulation, is the contents of the Directions for Use enclosed with the kits??

Please help :thanx:
 
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Al Rosen

Staff member
Super Moderator
#2
Gert Sorensen said:
Hi there,

Now it's my turn to turn to the cove for guidance.

We manufacture medical devices and sell them to our sister company in the US. They use the products for kits, pack, sterilize and sell them. We, however, hold the FDA registration of the products.

Whose responsibility, under FDA regulation, is the contents of the Directions for Use enclosed with the kits??

Please help :thanx:
I have no experience in this area, but according to, "Sterilized Convenience Kits for Clinical and Surgical Use; Final Guidance for Industry",
Labeling -
- The convenience kit should provide instructions for appropriate storage conditions and contain an expiration date supported by stability data. The expiration dates for device components should be revised based on data from your process validation studies for devices. The expiration date should not be longer than the shortest expiration date of any component in the kit.

For example, what is the impact on a kit's components when stored for one year at room temperature at 30 degrees centigrade? (See ICH, Q1A Stability Testing of New Substances and Products.) If you determine that the shortest expiration date is 3 months from the date of sterilization, that establishes the sterility expiration date for the entire kit.


- There is no specific policy in place with respect to labeling for device kits.
 

apestate

Quite Involved in Discussions
#3
Hmm, not that I have any specific experience in this area, but if I wanted to mesh out the details I would head directly to www.fda.gov/cdrh.

I would start by establishing the responsibilities of re-distributors, packers, and the like, and then move to part 801, labeling, of the code of federal regulations.

The CFR is maintained at the Government Printing Office, and it can be hard to navigate the regs because you are essentially searching out the bits you are looking for.
 

Al Rosen

Staff member
Super Moderator
#4
:2cents:Gert, if it was my decision and I was the person or entity listed as the manufacturer with FDA, I would provide the labeling. I think, otherwise it might prove to be troublesome in the future.
 
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