US Distributor Record Retention Requirements

Q

qamama

#1
I work for an IOL company that manufactures its devices outside the US.. These devices have an approved PMA and we now distribute them from our US headquarters (where I work) The US office is also listed as an alternate manufactuer of these same devices.

I believe we have to maintain distribution records to the final distributor on site here.....others disagree. IOLs are no longer considered to have tracking requirements. We are also ISO 13485 certified.

Help me to decide if we need to keep records here or can we send them to manufacture not in US? Or can we scan these records into a PDF format without worrying about part 11 compliance.
 
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M

MIREGMGR

#2
IOLs aren't my area of expertise, but I'll take a shot at this.

IOLs are no longer considered to have tracking requirements.
What is the reference for this? http: //www. fda. gov /MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/QualitySystemsRegulations/MedicalDeviceQualitySystemsManual/ucm122681.htm (DEAD 404 LINK DECOUPLED) indicates that 886.3600 does require trackability.

I work for an IOL company that manufactures its devices outside the US.
If the actual maker is legally part of your company, then the overall company is the Manufacturer and, to the extent that distribution record retention is required, must retain those records. If the company is unitary, it doesn't matter where the records are kept and retained, as long as they are readily available in the event of an Adverse Event report or for an FDA inquiry.

If the actual maker is a contract manufacturer and the US company is the Manufacturer, then to the extent required, the US company must retain the records.

If the actual maker is the Manufacturer and the US company is the Initial Importer and the distributor, either under the maker's name or on a private label basis, then the Manufacturer and the US company (as the Initial Importer) have joint responsibility for records.

The above is per US FDA only. Your ISO 13485 QS requires a separate analysis, although a conservative stance no doubt will satisfy both.
 
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