Dear Dr. Kasper:
Thank you for sharing the guidance document.
The term "component" has been defined under 21 CFR 820.3(c).
I interpret "component" as necessary versus "accessory" as "extra" or "optional."
Per the guidance document, the actual device is "Display" as it states "The devices are intended to provide display of digital mammographic images for review in the screening and diagnosis of breast cancer."
But the functional features of how the "Display" reveals can be viewed as "accessories" (e.g., 2D, 3D displays or both as display options).
For example, if a patient carries a device in his body (either implanted or extracorporeal assist devices), s/he may choose different sizes/colors of bags to carry the device or device component(s) (e.g., controller), wherein the bags in different sizes/colors can be accessories. Patients can choose whatever colors/sizes of bags...
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Original Message:
Sent: 04-26-2013 13:12
From: Kenneth Kasper
Subject: accessories, components, parts
For IVDs I have not used "accessory" to apply to calibrator kits or quality control kits that have been bundled in a 510(k) with assay reagent kits. My recollection is that an accessory can mean something required for safe and effective use of a device, but not a part or component of the device. For example, a plastic sample cup used on automated analyzers might fit this definition. Still, I would be interested in how others have used the term. Do others consider calibrators and controls as accessories? Is it optional?
I came across a guidance that has as its scope, accessories. The scope exludes the main device and its components, and it includes software items. You might find it an interesting model for understanding how accessories can be regulated.
Guidance for Industry and FDA Staff: Display Accessories for Full-Field Digital Mammography Systems-Premarket Notification (510(k)) Submissions
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm107549.htm#2
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Kenneth Kasper PHD
Executive Director, QA/RA
ARK Diagnostics, Inc.
Fremont CA
United States
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Original Message:
Sent: 04-25-2013 22:29
From: Michael Swit
Subject: accessories, components, parts
On the definition of "accessory," I recently researched whether an FDA-generated definition existed that would elaborate on this beyond its "dictionary" meaning. However, I was unable to find any clear guidance on how FDA defines "accessory" -- which is part of the definition of a device in Section 201(h) of the Federal Food, Drug, and Cosmetic Act.
You can get a sense of what FDA has regarded as an accessory by searching in the device classification regulations. As I recall, there are about 15 device classification regulations that inlcude the term "accessory" in the device identification statement. However, I also discussed this issue with a former ODE branch chief who told me that FDA has, at times, called things accessories that did not meet the plain definition of the term.
If you find something more on "accessory," would love to hear it.
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Original Message:
Sent: 04-22-2013 18:32
From: Dawn Chang
Subject: accessories, components, parts
I am looking for FDA's definition of accessories, components, and parts for both software and hardware. References to CRFs, guidance documents, etc. will be helpful. Can anyone provide some pointers? Thanks!
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Dawn Chang RAC
Mountain View CA
United States
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