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Hi Fellows,
Attached is the FDA Guidance on “Medical Device Accessories” from Dec, 2016.
Below is a concise summary of the main points for your learning.
Shimon
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1. Definitions:
Accessory: A finished device that is intended to support, supplement, and/or augment {enlarge / extent} the performance of one or more parent devices.
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.”
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.”
Parent Device: A finished device whose performance is supported, supplemented, and/or augmented by one or more accessories.
2. FDA has jurisdiction over accessories because the definition of the term “device” provided in Section 201(h) of the FD&C Act defines “device” to include, among other things, an “accessory”.
3. The policy governing the classification of accessories is subject to the same risk- and regulatory control-based scheme under the FD&C Act that FDA uses to classify all medical devices.
4. FDA has traditionally determined the classification of device accessory types in one of two ways: First, by inclusion in the same classification as the parent device. Second, by issuance of a unique, separate classification regulation for the accessory. FDA may consider issuing a separate classification regulation for a specific category of accessories that has been identified as having a different risk profile from that of the parent device and thus requires a different level of regulatory controls to provide reasonable assurance of safety and effectiveness of the accessories. For example,
5. Classifying an accessory in the same class as its parent device is appropriate when the accessory, when used as intended with the parent device, meets the criteria for placement in the class of the parent device. However, some accessories can have a lower risk profile than that of their parent device and, therefore, may warrant being regulated in a lower class.
.
Attached is the FDA Guidance on “Medical Device Accessories” from Dec, 2016.
Below is a concise summary of the main points for your learning.
Shimon
=====================\\.
1. Definitions:
Accessory: A finished device that is intended to support, supplement, and/or augment {enlarge / extent} the performance of one or more parent devices.
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.”
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.”
Parent Device: A finished device whose performance is supported, supplemented, and/or augmented by one or more accessories.
2. FDA has jurisdiction over accessories because the definition of the term “device” provided in Section 201(h) of the FD&C Act defines “device” to include, among other things, an “accessory”.
3. The policy governing the classification of accessories is subject to the same risk- and regulatory control-based scheme under the FD&C Act that FDA uses to classify all medical devices.
4. FDA has traditionally determined the classification of device accessory types in one of two ways: First, by inclusion in the same classification as the parent device. Second, by issuance of a unique, separate classification regulation for the accessory. FDA may consider issuing a separate classification regulation for a specific category of accessories that has been identified as having a different risk profile from that of the parent device and thus requires a different level of regulatory controls to provide reasonable assurance of safety and effectiveness of the accessories. For example,
5. Classifying an accessory in the same class as its parent device is appropriate when the accessory, when used as intended with the parent device, meets the criteria for placement in the class of the parent device. However, some accessories can have a lower risk profile than that of their parent device and, therefore, may warrant being regulated in a lower class.
.
