David, thank you for these references. I think I found what I was looking for in the guidance on product codes:
A product code is assigned to the device upon approval and is included in the subject of the approval letter of a PMA or HDE.
Class III devices are not always classified under a specific regulation, but may have a product code assigned. When a regulation for the device type exists, Class III devices are assigned under a specific regulation. When Class III devices are reclassified to Class II devices, a regulation is created and the product code may remain the same or a new product code may be created.
A classification product code may be assigned to a device that is the subject of an IDE submission and included in the approval letter for an IDE if the device falls in a known device area with established technology or will be tracked internally for a specific technology, patient population or device area. The classification product code assigned to a device that is the subject of an IDE application is primarily used for internal tracking purposes and may differ from that of the final PMA approval or 510(k) clearance.
I didn't realize that regulations are not routinely issued when a Class III device is approved, nor that a product code may also be issued for an IDE, so I think this answers my question.
It probably also answers my bigger question, which was how FDA might come to issue a product code for which there is both no classification regulation and no listed device. Apparently this must mean that an IDE has been submitted to conduct a trial of this type of device. The product code is probably one that was or is being used for internal tracking of the IDE, and may or may not be the code that is assigned to the device when and if it is finally approved or cleared for marketing.
If anyone can think of a different explanation, I'd be interested to hear....
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Julie Omohundro RAC
Durham NC
United States
Original Message:
Sent: 03-12-2015 22:27
From: David Lim
Subject: Device Product Codes without a Classification Regulation
Julie,
Under FDCA section 513(f), post-amendments devices are automatically classified in class III.
Under FDCA section 513(d), FDA promulgates device classification regulations based on "generic type," which means a grouping of devices based on purpose, design, materials, energy source, device function or any other feature pertaining to safety and effectiveness. Please refer to FDA guidance at http://wp.me/P4xpOK-Ri
As for product codes, in order to respond to the evolution of device technology, classification product codes were created to assist in accurate identification and tracking of current medical devices and to allow for tracking of and easy reference to predicate device types.
Please refer to FDA guidance at http://wp.me/P4xpOK-Rd
As for the product NIP, even though it is a class III device, requiring PMA, the corresponding device classification regulation covering "NIP" hasn't been promulgated yet.
David
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Dr. David Lim, Ph.D., RAC, ASQ-CQA "Knowledge is power only when it is practiced and put into action." - Regulatory Doctor
Original Message:
Sent: 03-12-2015 20:37
From: Julie Omohundro
Subject: Device Product Codes without a Classification Regulation
Does anyone know how FDA comes to issue a product code without promulgating a corresponding classification regulation?
For example product code NIP has the classification name "Stent, Superficial Femoral Artery," but there is no classification regulation for this type of device.
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Julie Omohundro RAC
Durham NC
United States
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