What are medical device accessories?
The attachment is a finished device used to support, supplement, and/or enhance the performance of one or more parent devices. The parent device is a completed device whose performance is supported, supplemented, and/or enhanced by one or more attachments. If labels, promotional materials, or other evidence of intended use indicate that the device is intended to support, supplement, and/or enhance other devices (whether of a specific brand or device type), then the device is considered an accessory. For example, an infusion pump system can include an infusion pump and a bracket. The bracket allows the infusion pump to maintain drugs and liquids at an appropriate height and facilitate patient or caregiver contact, thereby supporting the performance of the infusion pump. In this example, the bracket will be considered as an attachment to the infusion pump, and the infusion pump will be considered as the parent device.
It is important to note that items that do not meet the definition of accessories are not considered accessories simply because they may be used with the device. For example, mobile smartphones will not be considered accessories after downloading medical applications. Mobile smartphones are not considered accessories as they are not specifically designed for medical devices.
The FDA will classify attachments based on the expected risks of use and the level of regulatory control required to provide reasonable assurance for the safety and effectiveness of the attachments, although any other devices intended to use the attachments have been classified. The guidance document for medical device accessories - describing accessories and classification pathways - describes a risk and regulatory control based framework for accessory classification independent of the parent device classification, as well as the appropriate process for submitting requests for such accessory classification.
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What is an attachment classification request?
An attachment classification request is a written request submitted to the FDA under Section 513 (f) (6) of the FD&C Act, requesting appropriate classification of attachments. You can submit accessory classification requests for existing or new accessory types.
The existing types of accessories are those previously classified under the FD&C Act, cleared or approved in the PMA based on pre market notifications [510 (k)]. The existing attachment classification request is an independent request from a manufacturer or importer (i.e. not included in the PMA or 510 (k) application) who has sought to correctly classify the existing attachment types for their accessories.
The new types of accessories are those that were not previously classified under the FD&C Act, approved under 510 (k), or approved in the PMA. The new attachment classification request is a request included in the PMA or 510 (k) submission, used to correctly classify the new attachment type.
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How to submit a request for accessory classification
Attachment classification can be requested by submitting an attachment classification request Q-submit to the corresponding center's Document Control Center (DCC). Marketing submissions and attachment classification requests must be submitted in electronic format (eCopy). Once the FDA receives the submitted materials, any copies submitted will not be returned to the applicant.
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FDA review schedule and decisions
The FDA can approve or reject attachment classification requests.
·The FDA will approve or reject an existing attachment classification request within 85 days of receiving it.
·The FDA will approve or reject new accessory classification requests at the same time as deciding to submit new accessory classifications (e.g. 510 (k), PMA).
When an attachment classification request is approved, the FDA will issue a final classification order in the Federal Register, publicly notifying the decision and the classification of attachment types. If the FDA disagrees with the classification proposal submitted in the request, the submission and related decisions will not be made public, but a written response will be provided to the submitter, including the basis for rejecting the request.
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How will the FDA determine the classification of accessories?
The FDA intends to identify the risks associated with accessories and necessary control measures to ensure their safety and effectiveness in a reasonable manner, just like any other device classification. When determining the classification of accessories, the FDA will assess the risks associated with the impact of accessories on the parent device, as well as any unique risks associated with accessories that are independent of their parent device. Like any other device classification, the type of regulatory control required to control risks will determine the regulatory level of accessories.
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What information needs to be submitted in the accessory classification request?
New accessory types:
This request should be submitted together with the parent device submission and include the following content:
① A cover letter containing the following information:
a. Clearly indicate that the submitted content includes "new accessory requests" for new attachment types;
b. Identify attachments with different classification requirements from the parent device;
c. Determine the proposed classification of attachments (i.e. Class I or II)
② Necessary information based on the least tedious principle to determine the risk profile of attachments when used in conjunction with the parent device as expected.
③ If special controls are required under section 513 (a) (1) (B) of the FD&C Act, the request to classify accessories as Class II must include an initial draft proposal for special controls.
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