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.

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/medical-device-accessories-describing-accessories-and-classification-pathways

Тэги:

#Medical_Device_Academy #Component_Device #Accessory_Device #Finished_Device #Parent_Device

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