Listing a Preamendment Medical Device

A

AJayC

#1
Our company is considering a Private Labeled - 510K Class II devicefrom an OEM. Per the OEM, it is preamendment device.

The OEM would place our Private Label on the device and ships it to our Mexico facility. From the Mexico location the product would be shipped into the USA to our customers. Also, some product will be repackaged in smaller quantities (example: A 500 unit box repackaged as 100 units per box.)

Since the OEM does not have a 510K, would we need a 510K?
How should this be registered with the FDA as a repackager or relabler?
 
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M

MIREGMGR

#2
Listing a preamendment device.

Note that this isn't a Class II device if it's Preamendment. Preamendment is an alternate status to Class II.

I can envision some potential glitches.

1. Will this device be marketed in Mexico? If so, COFEPRIS approval might require jumping through some hoops, depending on how much attention is paid to the device classification and its US-maker Listing status.

2. You don't need a 510(k) of your own if you are a Private Label Distributor. You also don't Register or List.

3. If however you Repackage, you must Register and List. I don't know how Preamendment status is handled through a Repackager. Repackaging status is one of the ways that kit packing is regulated, when the objects being repackaged/combined are already legally devices. I've never dealt with that situation when the involved product was Preamendment. That however must be a common situation, so I'm sure DSMICA could point you to an answer.

4. Will you be combining the Preamendment device with other products and/or doing sterilization etc.?

5. When the devices re-enter the country, an FDA PREDICT declaration will be needed. You'll have to declare the original Manufacturer for that purpose. I've heard that Preamendment devices can be complicated in the PREDICT system, which isn't exactly well documented. You might want to talk to the PREDICT people about that well in advance of your first shipment.
 
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A

ascherp

#3
Hello,

A Class 2 device can be either preamenment or 510(k), depending on when it was placed into commercial distribution in the United STates. If it was legally marketed prior to May 28, 1976, has not been significantly changed since then nor is marketed for a new intended use, it is preamendment.

Preamendment status needs to be demonstrated by the appropriate documentation. You can find guidelines on preamendment requirements at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/ComplianceActivities/ucm072746.htm

Ask your OEM for a copy of his preamendment documentation and check to see if it complies with the guidelines. If you're not sure, you can submit the documents to the FDA with the form mentioned in the guidance or call the Office of Compliance at the number provided there as well.

If you can confirm the documentation is ok, you can compare the current device with the one marketed before 1976 according to the guidelines provided in "Deciding When to Submit a 510(k) for a Change to an Existing Device" (510k Memorandum #K97-1). If you come to the conclusion that the current device meets the requirements listed there for a new 510(k) submission, either you or the manufacturer should submit a 510(k) before marketing it.

Your facility in Mexico is a Repackager and should list the (preamendment or 510k) device as such.

Since your name is provided on the device itself and on the packaging, if I understand you correctly, and you aren't just adding your name to the otherwise original labeling, you are a Relabeler and will need to list the (preamendment or 510k) device as such.

Good luck! I hope you can confirm it's preamendment.:)
 
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