Do you know the difference between a medical device component and an accessory medical device?

Definition of an accessory: A finished device that is intended to support, supplement, and/or augment the performance of one or more parent devices.
Definition of a Component (21 CFR 820.3(c)): “[A]ny raw material, substance, piece, part, software, firmware, labeling, or assembly which is intended to be included as part of the finished, packaged, and labeled device.”
Definition of a Finished Device (21 CFR 820.3(l)): “[A]ny device or accessory to any device that is suitable for use or capable of functioning, whether or not it is packaged, labeled, or sterilized.”
Definition of a Parent Device: A finished device whose performance is supported, supplemented, and/or augmented by one or more accessories.
What are some examples of device components?
What are some examples of device accessories?
Is there FDA guidance on medical device accessories? Yes, the FDA has a 2017 guidance document describing medical device accessories and the regulatory pathways.
www.fda.gov/regulatory-inform...

[@luisenriqueramirezrojas241]

Rob, this is in the spirit of MDR definition for accessories, so it might be a little different from FDA. MDR defines accessory as "an article which, whilst not being itself a medical device, is intended by its manufacturer to be used together with one or several particular medical device(s) to specifically enable the medical device(s) to be used in accordance with its/their intended purpose(s)". I am struggling with the "not a medical device itself". For example, let's think of a IV pump with a dedicated admin set. The pump simply is useless without the admin set and vice versa. In this case, is the whole system the medical device or is the admin set an accessory to the pump? Or, on the other hand, can you say that the pump and admin set are, each one on their own, medical devices even when they do not function unless you use them together? Sorry for the long question.

[@MedicalDeviceAcademy]

That's definitely an advanced question that might be beyond the knowledge level of most people, but I'm happy to answer it. In the EU, the IV pump and the admin set are both medical devices and not accessories. In the USA, we use the word "accessory" more casually and we say that something is an accessory to a device. In the EU the IV pump is a drug delivery device (i.e., Rule 12, Class IIb), and the admin set is also a device, but the intended use is "as channels in active drug delivery system" (i.e., Rule 2, Class IIa). Both of these are clearly identified as examples in the MDCG Guidance 2021-24. health.ec.europa.eu/system/files/2021-10/mdcg_2021-24_en_0.pdf
If your company was developing both as a system, you would apply for CE Marking of the system. However, you can also apply for CE Marking of either device individually, and the device can be intended for use with another device. It may not be functional without the other device, but it does not meet the definition of an accessory in the MDR.
An example of an accessory in the MDCG Guidance is "a suture organiser." A foot pedal switch used in an OR to turn on an off a device would be an accessory in the MDCG guidance as well.
In the realm of software, the answer may be more confusing. In this case you should refer to the infographic provided in MDCG guidances for "Is your software a medical device?" (i.e., MDSW)

[@Jslotau8]

Hi Rob, thank you for making a video on this topic! Can you please describe in more detail the process of getting a medical device FDA cleared if the device is a new accessory (has no utility on its own) that augments a currently 510(k) cleared class II device made by a different company? Thank you!

[@MedicalDeviceAcademy]

Great question, but to understand this I will use an accessory. For example, a monopolar electrocautery device is a device. The holster that the pen would be placed in is an accessory. There is no separate product code that was created for the accessory, but you can get 510(k) clearance for just the holster. You can find a predicate submission that is just a holster or you can use a submission for pen with a holster. In the first case it is straightforward. In the second case, you need to clarify that you are only submitting a 510(k) for the holster and claiming equivalence to the holster--not the pen. Therefore the indications will probably be different from what the predicate has if the predicate is the device and the accessory. It doesn't matter if the accessory is for a competitor product or not, but you will need to show compatibility testing OR you can provide specifications for what devices it can work with.

[@mayankkapoor217]

HEY ROB..CAN YOU HELP ME WITH THE CLASSIFICATION OF TENS ELECTRODE.. WHETHER TENS ELECTRODE USED IS AN ACCESSORY OR A PART TO THE TENS UNIT MACHINE?

[@MedicalDeviceAcademy]

You're making work hard. I had to actually look this up. GZJ and NUH are the most common product codes used for a TENS device. IPF and NGX are a couple of other codes commonly used. Usually companies include the electrode with the controller and software as a system under the primary code. However, there are electrodes that are separately cleared via a 510(k). GXY is for cutaneous electrodes. I have also seen people include cables that act as an connection between the controller and the electrode. Cables are 510(k) exempt under the IKD product code. There is also a 3-page FDA guidance on cables and electrode wires: www.fda.gov/medical-devices/guidance-documents-medical-devices-and-radiation-emitting-products/electrosurgical-devices-and-application-performance-standard-electrode-lead-wires-and-patient-cables

[@MedicalDeviceAcademy]

You're making work hard. I had to actually look this up. GZJ and NUH are the most common product codes used for a TENS device. IPF and NGX are a couple of other codes commonly used. Usually companies include the electrode with the controller and software as a system under the primary code. However, there are electrodes that are separately cleared via a 510(k). GXY is for cutaneous electrodes. I have also seen people include cables that act as an connection between the controller and the electrode. Cables are 510(k) exempt under the IKD product code. There is also a 3-page FDA guidance on cables and electrode wires: www.fda.gov/medical-devices/guidance-documents-medical-devices-and-radiation-emitting-products/electrosurgical-devices-and-application-performance-standard-electrode-lead-wires-and-patient-cables

[@mayankkapoor217]

Thanks and your hard work is much appreciated brother!

[@arunasharma9432]

So, it might be a stupid question but just to have a clear understanding of the definition what would band-aid and glue used in band-aid be considered?

[@MedicalDeviceAcademy]

Band-aid is a brand name for a wound dressing (i.e., product classification code FRO). There are many variations on the market, but typically they are sterile, have an absorbent pad for wound exudate, and they have an adhesive to ensure that the dressing stays in place. It is essential the combination of tape and gauze into one product.
Topical adhesives are typically cyanoacrylate adhesives that can be used to approximate tissue for a laceration. Adhesives can also be used internally for lacerations of the liver, spleen, etc. Typically, topical adhesives are used with sutures.