Questions: Plastic Food Container to comply with FDA

L

luloo117117

Hello,

A plastic food container manufacturer (named company A) located out of U.S.A. The container cover material is PET and the bottom part is PP (refer to the attached picture). This food container is used for home or commercial food industy. I do not know what company A should do to go through FDA and sell to U.S. market.

very appreciate
 

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L

luloo117117

Very appreciate. Could you give more detailed directions please?

:)
 
L

luloo117117

Does our plastic product need FDA approval as Class II medical device with 510k approval letter? or just notify FDA without getting any approval.

Thanks
 
M

MIREGMGR

luloo117117 said:
Does our plastic product need FDA approval as Class II medical device with 510k approval letter? or just notify FDA without getting any approval.
Click to expand...

??? You said in the OP that it's a Food container...?

The FDA implements three (sort of) independent regulatory systems: medical devices, pharma, and food. A given item (usually) belongs to just one of them. Do not use rules from one system for an item belonging to another system.

510(k) premarket notification applies only to medical devices.

Read all of the information in Harry's link above, which explains the food container/packaging system.
 
L

luloo117117

Dear MIREGMGR

Thanks for your recommendation.

Leon

MIREGMGR said:
??? You said in the OP that it's a Food container...?

The FDA implements three (sort of) independent regulatory systems: medical devices, pharma, and food. A given item (usually) belongs to just one of them. Do not use rules from one system for an item belonging to another system.

510(k) premarket notification applies only to medical devices.

Read all of the information in Harry's link above, which explains the food container/packaging system.
Click to expand...
 
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