When clients are pondering various business models and wondering if they are "possible", I often tell them that the regulatory requirements will accommodate pretty much any business model you can invent. So the answer is invariably, "Yes, we can do that". But the real question is whether the corresponding regulatory pathway/strategy will be feasible for the business plan.
Regarding medical device repackaging and relabeling, FDA has officially defined these terms. And those definitions will dictate the applicable regulatory requirements. Specifically, a repackager is someone who packages finished devices from bulk or repackages devices made by a manufacturer into different containers (excluding shipping containers). A relabeler is someone who changes the content of the labeling from that supplied from the original manufacturer for distribution under the establishment's own name. Yet a relabeler does not include establishments that do not change the original labeling but merely add their own name (e.g., by adding a sticker that doesn't obscure the manufacturer's labeling). These terms are significant because FDA considers them to be forms of manufacturing operations, thus triggering the applicable regulatory requirements that, in general, apply to any manufacturer.
Specifically, if a firm's business model involves doing true repackaging or relabeling, then key regulatory requirements include, but may not be limited to:
- FDA Establishment Registration as a repackager and/or relabeler
- Medical Device Listing(s) for the repackaged and/or relabeled devices
- Submit for premarket authorization [e.g., 510(k), PMA, etc.] where applicable depending on device class
- Comply with GMP here applicable depending on device class
If on the other hand the plan is to be a wholesale distributor who is just distributing another manufacturer's devices that are private labeled for the wholesale distributor so that only its name and brand are on the product, then such wholesale distribution is exempt from the aforesaid regulatory controls, with one exception. Specifically, as a general rule, any finished device contract manufacturer shall register, list, and comply with GMP. So, if the wholesale distributor also happens to be the one repackaging and relabeling to realize the private label version of another manufacturer's device and is doing so in accordance with that manufacturer's DMR and under that manufacturer's authorization and supervision, then that is a finished device contract manufacturing operation, thus triggering establishment registration, device listing, and GMP obligations. However, the premarket authorization requirement [i.e. 510(k), PMA, etc.] still remains with the OEM.
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Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
Ridgway, CO
United States
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Original Message:
Sent: 05-Apr-2023 00:42
From: Shikha Malik
Subject: Repackaging and relabeling
Hello!
Is it possible to re-package and re-label an OUS medical device (class II 510(k) cleared) for the US marker? If yes, in what conditions this action is permitted? Also, what are the conditions/criteria and implications for the same?
Looking forward to some valuable inputs.
Thanks!
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Shikha Malik
Sr. Regulatory Affairs Specialist
Frisco TX
United States
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