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Medical Device Accessories

On August 18, 2017, section 513(f) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) was amended by the FDA Reauthorization Act of 2017 (FDARA; Pub. L. 115-52) to state that "the Secretary shall … classify an accessory under [section 513] based on the risks of the accessory when used as intended and the level of regulatory controls necessary to provide a reasonable assurance of safety and effectiveness of the accessory, notwithstanding the classification of any other device with which such accessory is intended to be used." In addition, FDARA added the new section 513(f)(6) to the FD&C Act, which created new pathways to request a different classification for an accessory from its parent device. These Accessory Classification Requests enable the classification of accessories to reflect the risks of the accessory when used as intended and with the level of regulatory controls necessary to provide a reasonable assurance of safety and effectiveness of the accessory. For example, an accessory to a class III parent device may pose lower risk that could be mitigated through general controls, or general and special controls, and thus could be regulated as class I or class II, respectively.

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What is a medical device accessory?

An accessory is a finished 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 is supported, supplemented, and/or augmented by one or more accessories. If labeling, promotional materials, or other evidence of intended use demonstrates that the device is intended to support, supplement, and/or augment another device, whether a particular brand or a device type, that device is considered an accessory. For example, an infusion pump system may include an infusion pump and a stand. The stand supports the performance of the infusion pump by allowing the infusion pump to hold medications and liquids at an appropriate height and in convenient reach of the patient or caregiver. In this example, the stand would be considered the accessory to the infusion pump, and the infusion pump would be considered the parent device.

It is important to note that articles that do not meet the definition of an accessory will not be treated as accessories simply because they may be used in conjunction with a device. For example, a mobile smart phone would not be considered an accessory after having downloaded a medical application (app). The mobile smart phone would not be considered an accessory because it was not specifically intended for use with the medical device.

FDA will classify an accessory based on the risks of the accessory when used as intended and the level of regulatory controls necessary to provide a reasonable assurance of safety and effectiveness of the accessory, notwithstanding the classification of any other device with which such accessory is intended to be used. The guidance document Medical Device Accessories - Describing Accessories and Classification Pathways  describes the risk- and regulatory control-based framework for the classification of accessories separate from the classification of parent devices and the appropriate processes for submitting such an Accessory Classification Request

What is an Accessory Classification Request?

An Accessory Classification Request is a written request submitted to the FDA under section 513(f)(6) of the FD&C Act for requesting the appropriate classification of an accessory. An Accessory Classification Request may be submitted for an existing accessory type or a new accessory type.

An existing accessory type is an accessory that has been previously classified under the FD&C Act, cleared under a premarket notification [510(k)], or approved in a PMA. An Existing Accessory Classification Request is a standalone request (i.e., not included as part of a PMA or 510(k) application) from a manufacturer or importer who already has marketing authorization for their accessory seeking proper classification of an existing accessory type.

A new accessory type is an accessory which has not been previously classified under the FD&C Act, cleared under a 510(k), or approved in a PMA. A New Accessory Classification Request is a request included in a PMA or 510(k) submission for proper classification of a new accessory type.

Is there a Medical Device User Fee Amendments (MDUFA) User Fee associated with an Accessory Classification Request?

There are no distinct MDUFA user fees associated with an Accessory Classification Request; however, if the Accessory Classification Request is submitted as part of a 510(k) or PMA application, the fees for the 510(k) or PMA application still apply.

Information on user fees is located on the MDUFA user fee page. The applicable fee corresponds with the date the FDA received the submission. Please note, the FDA will consider the 510(k) or PMA application incomplete and will not begin the review until the fee is paid in full.

If the submitter meets the definition of a small business, the parent device submission with which an Accessory Classification Request is included may qualify for a reduced fee. For further information on the MDUFA Small Business determination Program and Eligibility, please reference the Small Business Guidance Document.

How to Submit an Accessory Classification Request

You can request an Accessory Classification by submitting an Accessory Classification Request Q-Submission to the appropriate Center’s Document Control Center (DCC). The mailing address for CDRH's DCC and a link to the Center for Biologics Evaluation and Research’s (CBER) DCC's mailing address are provided on the eCopy Program for Medical Device Submissions webpage.

The marketing submission and the Accessory Classification Request must be submitted in an electronic format (eCopy). Once a submission is received by the FDA, the submission or any copies will not be returned to the applicant.

Although not a requirement, the FDA recommends submitting an Accessory Classification Request using a method that will provide a signed receipt of delivery, e.g., registered mail with a return receipt or a commercial delivery service. Please see the Frequently Asked Questions for more specifics on what information should be submitted in an Accessory Classification Request.

FDA Review Timeline and Decisions

FDA may grant or deny an Accessory Classification Request.

  • FDA will grant or deny an Existing Accessory Classification Request within 85 days of receiving the request.
  • FDA will grant or deny a New Accessory Classification Request concurrently with the decision on the marketing submission (e.g., 510(k), PMA) with which the request was submitted.

When an Accessory Classification Request is granted, FDA will publish a final classification order in the Federal Register providing public notice of the decision and the classification of the accessory type. If FDA does not agree with the recommendation for classification submitted in a request, the submission and associated decision will not be made public, but a written response will be provided to the submitter that includes the basis for the denial of the request.

Medical Device Accessory Classification Request Granting Decisions

Frequently Asked Questions (FAQs)

1. What are the different options/pathways for the classification of accessories?

New Accessory Type:

A request for a different classification from the parent device can be requested for new accessories through one of the following pathways:

  1. New Accessory Request for a new accessory type (section 513(f)(6)(C) of the FD&C Act); this request should be submitted together with the parent device submission.
  2. De Novo Classification Request (section 513(f)(2) of the FD&C Act); this request should be submitted separately from the parent device submission, such as for a new accessory type intended to be used with a parent device that is already legally marketed. Note that there is a MDUFA user fee associated with De Novo requests.

Existing Accessory Type:

A request for a different classification from the parent device can be requested for existing accessories that already have marketing authorization through one of the following pathways:

  1. Existing Accessory Request for an existing accessory type (section 513(f)(6)(D) of the FD&C Act)
  2. Reclassification under section 513(e) or 513(f)(3) of the FD&C Act

In addition, FDA will issue proposed lists of accessories that FDA believes are suitable for distinct classification into class I at least every 5 years after the enactment of FDARA and as FDA otherwise determines appropriate. There will be at least a 60-day public commenting period when proposed lists are published, and we encourage interested parties to provide comments on such lists.

2. How will FDA determine an accessory’s classification?

FDA intends to determine the risk of accessories and the controls necessary to reasonably assure their safety and effectiveness in the same way used for any other device classification. In determining the classification of an accessory, the FDA will evaluate the risks posed by the accessory’s impact on the parent device and any unique risks of the accessory independent of its parent device. As with the classification of any other device, the types of regulatory controls necessary to control the risks will determine the regulatory class for accessories.

3. What information do I need to submit in my Accessory Classification Request?

New Accessory Type:

This request should be submitted together with the parent device submission and include the following:

  • A cover letter including the following information:
    • a clear identification that the submission includes a "New Accessory Request" for a new accessory type;
    • identification of the accessory for which a different classification from the parent device is being requested;
    • identification of the proposed classification of the accessory (i.e., class I or class II)
  • The necessary information, based on Least Burdensome principles, to establish the risk profile of the accessory when used as intended with the parent device.
  • Requests for classification of an accessory into class II must include an initial draft proposal for special controls, if special controls would be required pursuant to subsection 513(a)(1)(B) of the FD&C Act.

Existing Accessory Type:

The Accessory Classification Request should include the following:

  • A cover letter including the following information:
    • a clear identification that the submission includes an "Existing Accessory Request" for an existing accessory type;
    • identification of the accessory or accessories for which a different classification from the parent device is being requested,
    • The current and proposed classification of the accessory or accessories (i.e., class I or class II),
  • The necessary information, based on Least Burdensome principles, to establish the risk profile of the accessory when used as intended with the parent device.
  • Requests for classification of an accessory into class II must include an initial draft proposal for special controls, if special controls would be required pursuant to subsection 513(a)(1)(B) of the FD&C Act.

4. When should I approach FDA if I am considering requesting classification of an accessory?

FDA recommends manufacturers consult with FDA prior to submitting an Accessory Classification Request. The most appropriate way to request such feedback is through a Pre-Submission (Pre-Sub). Additional information on Accessory Classification Requests can be found in the FDA guidance Medical Device Accessories - Describing Accessories and Classification Pathways.

5. Do the accessory classification pathways apply to software products intended to be used for medical purposes?

The accessory classification pathways apply to software used for medical purposes, including software that meets the definition of Software as a Medical Device (SaMD) provided by the International Medical Device Regulators Forum, and/or if it meets the definition of an accessory provided in FDA’s accessory guidance. Regardless of whether software meets either of these definitions, the Agency intends to apply the same risk- and regulatory control-based classification approach discussed in this guidance. However, it should be noted that software that uses data from a medical device does not automatically become an accessory to a medical device.

6. Do accessories require a Unique Device Identification (UDI)?

The UDI requirements apply to all medical devices per 21 CFR 801.20, including medical device accessories, unless an exception or alternative applies or was granted pursuant to 21 CFR 801.30 or 801.55.

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