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Posted on Oct 20, 20201
The Federal Food, Drug and Cosmetic Act (FD&C Act) has been amended by the FDA Reauthorization Act of 2017 (FDARA; Pub. L. 115-52) to state that "The Secretary ... will classify the additive in accordance with [Art. 513] on the risks associated with the accessory used as intended and the level of regulatory controls necessary to provide reasonable assurance about the safety and effectiveness of the accessory, irrespective of the classification of any other device with which such accessory is intended to be used. "
In addition, FDARA added a new section 513 (f) (6) to the FD&C Act which created new paths to request a different classification of an accessory from its parent device. These Accessory Classification Requests allow the classification of the accessories to reflect the risks associated with the accessories when used as intended and at the level of regulatory controls necessary to provide reasonable assurance about the safety and effectiveness of the accessory. For example, an accessory for a class III parent product may present a lower risk that could be mitigated by general checks or general and specific controls and therefore may be regulated as Class I or Class II, respectively.
An accessory is a ready-made device that is intended to support, complement and / or enhance the operation of one or more master devices. A master device is a ready-made device whose performance is supported, supplemented, and / or enhanced by one or more accessories. Where labels, promotional material, or other evidence of intended use indicate that the device is intended to support, complement and / or extend another device, be it a specific brand or device type, then the device is considered an accessory. For example, an infusion pump system may include an infusion pump and a rack. The stand supports the operation of the infusion pump allowing the infusion pump to hold medications and fluids at the appropriate height and within the convenient reach of the patient or caregiver. In this example, the rack would be considered an accessory for the infusion pump and the infusion pump as the master device.
Note that articles that do not meet the definition of an accessory will not be considered accessories just because they can be used in conjunction with the article. For example, a smart cell phone would not be considered an accessory after downloading a medical application (application). A mobile smartphone would not be considered an accessory as it was not specifically intended for use with a medical device.
The FDA will classify the accessory based on the risk associated with the accessory, when used as intended, and the level of regulatory controls necessary to provide reasonable assurance about the safety and effectiveness of the accessory, regardless of the classification of any other device with which such accessory is intended to be used. The guidance document Medical
Describing accessories and classification pathways describes a framework based on risk control and regulations for the classification of accessories separately from the classification of parent devices and the appropriate processes for submitting such an application for classification of accessories.
An accessory classification request is a written request to the FDA pursuant to section 513 (f) (6) of the FD&C Act to obtain the appropriate classification of the accessory. A request for an accessory classification can be made for an existing type of accessory or for a new type of accessory.
An existing accessory type is an accessory that has been pre-classified under the FD&C Act, approved with a pre-market notification [510 (k)], or approved by the PMA. An existing accessory categorization application is a standalone application (i.e. not part of a PMA or 510 (k) application) from a manufacturer or importer who already has authorization for their accessory seeking proper classification of an existing accessory type.
A new type of accessory is an accessory that has not been previously classified under FD&C, 510 (k) approved or PMA approved. A new accessory classification request is a request included in the submission of a PMA or 510 (k) to properly classify a new type of accessory.
There are no separate MDUFA user charges for an accessory classification request; however, if an Accessory Classification Request is submitted as part of a 510 (k) or PMA application, the 510 (k) or PMA application fees will still apply.
Information on user charges can be found on the MDUFA user charges page. The applicable fee is the date the filing was received by FDA. Please note that the FDA will consider the 510 (k) or PMA application incomplete and will not proceed with the review until the fee is paid in full.
If an applicant meets the definition of a small company, an entry for a parent machine that has an accessory classification application attached to it may qualify for a reduced fee. For more information on the MDUFA Small Business Determination Program and eligibility, see the Small Business Guidelines document.
You can request an Accessory Classification by submitting a Q-Submission Accessory Classification Request to the appropriate Document Control Center (DCC) of the appropriate Center. The DCC CDRH mailing address and a link to the DCC Biological Assessment and Research Center (CBER) mailing address are provided on the eCopy Program for Medical Device Submissions website.
The marketing application and the application for the classification of accessories must be submitted in electronic format (eCopy). Once an application has been received by the FDA, the application and any copies will not be returned to the applicant.
While not required, the FDA recommends that you submit a request for accessory classification using a method that will provide a signed delivery note, such as Registered Mail with Delivery Note or a commercial delivery service. See the frequently asked questions for more details on what information should be provided in an accessory classification application.
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