Unless you changed the IFU to address a risk, I don't think simply sending an IFU falls into these requirements. While, for a marketed device, sending the IFU separately could be deemed a "Correction" the intent in 812 seems to be around the device and reasons it would need to be "fixed" or might present some risk that was previously not disclosed. In IDE studies, it isn't that unusual for the IFU to go either with the IB or be hand carried, rather than packaged with the devices. As long as the investigator has it and has read it prior to enrolling patients, I don't think this reporting is necessary.
g-
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Ginger Glaser RAC
Vice-President, Quality and Regulatory Affairs
Maplewood MN
United States
Original Message:
Sent: 16-Aug-2016 10:40
From: Brian Young
Subject: IDE Recall & device disposition reporting
Clinical trial sponsors of med device IDE studies are required to notify "FDA and all reviewing IRB's of any request that an investigator return, repair or otherwise dispose of any units of a device" pursuant to the reporting requirements in 21CFR 812.150(b)(6) (here).
I searched for FDA's definition of "repair" and didn't find anything definitive. There is a proposed definition in the March 4, 2016 Federal Register Notice for refurbishing, reconditioning, rebuilding, ..... medical devices (here). The proposed definition is "Return the device or component to original specifications including replacing non-working components or parts outside of routine or periodic upkeep for the current owner of the device." I would be interested in hearing other's interpretation regarding whether sending an investigational IFU to investigators who didn't receive it with the original shipment would trigger the need for FDA and IRB reporting under the IDE regulation.
Thanks!
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Brian Young
Parenteau BioConsultants, LLC
Boerne, TX
United States
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