Draft Guidance – Defining Accessories and Classification Pathway for New Accessory Types

The clients are being made aware of the recent guidance that FDA released on its current thinking on defining accessories classification pathway for new accessories and has opened it for comment.

FDA defines accessory as a device that is intended to support, supplement, and/or augment the performance of one or more parent devices. A parent device is a finished device whose performance us supported, supplemented, and/or augmented by one or more accessories.

To determine if a device is an accessory, FDA will ask the following questions:

1. Is it intended for use with one or more parent devices
2. Is it intended to support, supplement, and/or augment the performance of one or more parent devices

FDA will determine the risk of an accessory based on its use with the parent device. This does not mean that all risks of a parent device are imputed to the accessory. To classify an accessory, FDA encourages the De Novo process. A request for accessory De Novo classification should include some of the following elements:

• Clear identification as a de novo request for a new accessory device
• Device Information and Summary:
   ∘ A description of the relevant parent device(s);
   ∘ A description of the ability for the accessory to be compatible with a specific parent device or a class of devices;
   ∘ A description of the technical characteristics of the accessory, which ensure compatibility with a specific parent device or a class of devices;

• Identification of products to which the accessory is compatible, including model number, connector type, etc.
• Classification summary and recommendation:
   ∘ The classification summary should include a rationale for why the accessory device does not fit within any identified classification for the parent device(s);
• An identification of the risks to health presented by the accessory device and proposed mitigation measures;
• Proposed controls:
   ∘ For class II devices, list of general and special controls that sufficiently mitigate the risks to health, including compatibility of the accessory device with parent device, and applicability of 510(k) for future devices11 and a description of how the proposed special controls will provide a reasonable assurance of safety and effectiveness for the accessory device
   ∘ For class I devices, an identification of how the application of general controls only would sufficiently mitigate the risks to health

• Benefit/Risk Considerations

I For knowing about in-depth requirements about this classification pathway please refer to Medical Device Accessories: Defining Accessories and Classification Pathway for New Accessory Types

?For any questions regarding the rule please contact us at [email protected] or use or contact info form. Ref: Accessory Classification