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Referencing Medical Device in FDA records - Package contains several other components

J

Jnks_Meddev

#1
Hi Everyone,

I just came across this information and I am trying to find if there is any FDA guidance that explains this concept?

so my current company is selling a class IIa device in package form, the package contains several other components that are manufactured by our clients.

Our client can send their device for approval and reference our FDA approved device for further information to get the entire package approved. Can someone explain me if this is possible and what regulation/guidance provides more details on this.

Thank you!
 
Elsmar Forum Sponsor

Al Rosen

Staff member
Super Moderator
#2
Hi Everyone,

I just came across this information and I am trying to find if there is any FDA guidance that explains this concept?

so my current company is selling a class IIa device in package form, the package contains several other components that are manufactured by our clients.

Our client can send their device for approval and reference our FDA approved device for further information to get the entire package approved. Can someone explain me if this is possible and what regulation/guidance provides more details on this.

Thank you!
I don't know much about this, but I believe you can start here :Convenience Kits Interim Regulatory Guidance
 
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