Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Greetings,

My company manufacturers class I and II devices for sale in the U.S., but we also have an export only device.

We have a new situation: we designed and developed a device, but the manufacturing will occur in China and the device will be drop shipped from our CM in China to Japan where the device is being registered.

Since my company holds the specification/tech file I believe we are legally responsible for the safety of the device and our company address must be listed on the label as the manufacturer. Please correct me if I'm wrong.

Note, sales orders would go through us in the U.S.

Given this unique situation, do we list as the Specification Developer for this device or as something else? The device will not be marketed/sold in the U.S. until we submit the 510(k) in the distant future.

Thank you in advance.

Hello Anon

Listing a device before it has clearance is an interesting situation. There is some information about how FDA can handle that in the guidance on Medical Device Classification Product Codes.

https://www.fda.gov/media/82781/download

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Anne LeBlanc
United States
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Original Message:
Sent: 14-Jun-2022 19:35
From: Anonymous Member
Subject: Manufacturer vs Spec Developer

This message was posted by a user wishing to remain anonymous

Greetings,

My company manufacturers class I and II devices for sale in the U.S., but we also have an export only device.

We have a new situation: we designed and developed a device, but the manufacturing will occur in China and the device will be drop shipped from our CM in China to Japan where the device is being registered.

Since my company holds the specification/tech file I believe we are legally responsible for the safety of the device and our company address must be listed on the label as the manufacturer. Please correct me if I'm wrong.

Note, sales orders would go through us in the U.S.

Given this unique situation, do we list as the Specification Developer for this device or as something else? The device will not be marketed/sold in the U.S. until we submit the 510(k) in the distant future.

Thank you in advance.