Accessory Classification Request
Understanding Medical Device Accessories
A medical device accessory is a fully functional device designed to enhance or support the performance of one or more primary devices. This enhancement can take various forms, such as providing additional support, supplementing existing features, or augmenting overall performance. An accessory is characterized by its clear intention to improve the operation of another device, whether it’s a specific brand or a type of device. For example, consider an infusion pump system consisting of an infusion pump and a stand. The stand’s purpose is to enhance the performance of the infusion pump by ensuring medications and liquids are held at an appropriate height and are easily accessible to patients or caregivers. In this scenario, the stand is classified as the accessory to the infusion pump, which serves as the primary device.
The classification of a medical device accessory is based on an evaluation of its risks in its intended use and the level of regulatory control necessary to ensure its safety and effectiveness. This classification is determined independently of the primary device’s classification, focusing solely on the accessory’s characteristics and intended purpose. The FDA provides guidance on how to describe accessories and the classification pathways, outlining a risk- and regulatory control-based framework for appropriately categorizing accessories separate from their primary devices.
What is an Accessory Classification Request?
An Accessory Classification Request is a formal written submission to the FDA according to section 513(f)(6) of the FD&C Act, used to request the appropriate classification of a medical device accessory. This request can apply to either an existing accessory type or a new one.
An existing accessory type refers to an accessory that has already been classified under the FD&C Act, cleared through a premarket notification (510(k)), or approved via a PMA. A manufacturer or importer who already has marketing authorization for such an accessory can submit an Existing Accessory Classification Request as a separate request (not part of a PMA or 510(k) application) to ensure the correct classification of the existing accessory type.
On the other hand, a new accessory type is an accessory that hasn’t been previously classified under the FD&C Act, cleared through a 510(k), or approved through a PMA. A New Accessory Classification Request for a new accessory type is included as part of a PMA or 510(k) submission, seeking the appropriate classification for the new accessory type within the context of the primary device’s regulatory application.
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).
How to Submit an Accessory Classification Request?
To submit an Accessory Classification Request to the FDA, you should prepare your request and marketing submissions in an electronic format (eCopy) and submit them as 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 CBER’s DCC can be found on the eCopy Program for Medical Device Submissions webpage. While not mandatory, the FDA recommends using a method that provides a signed receipt of delivery, such as registered mail with a return receipt or a commercial delivery service, to ensure confirmation of receipt of your Q-submission. Once received, the FDA does not return the submission or any copies.
What are the different options for the classification of accessories?
New Accessory Type
New Accessory Request for a new accessory type: This pathway, defined by section 513(f)(6)© of the FD&C Act, involves submitting a request for a different classification alongside the primary device submission. It’s used when introducing a completely new type of accessory that requires a distinct classification from the primary device.
De Novo Classification Request: Governed by section 513(f)(2) of the FD&C Act, this option requires submitting a request separately from the primary device submission. It’s suitable when introducing a new accessory type intended for use with a primary device that is already legally marketed. However, it’s important to note that there is an associated MDUFA user fee for De Novo requests.
Existing Accessory Type
Existing Accessory Request for an existing accessory type: This pathway, outlined in section 513(f)(6)(D) of the FD&C Act, is applicable to existing accessories that already have marketing authorization but require a different classification from the primary device.
Reclassification under section 513(e) or 513(f)(3) of the FD&C Act: This option involves requesting a reclassification of an existing accessory type. It’s typically based on new information or changes in technology that warrant a different classification.
Additionally, the FDA periodically issues proposed lists of accessories suitable for distinct classification into class I, as mandated by FDARA. These lists allow for a public commenting period of at least 60 days after publication, providing an opportunity for interested parties to provide input on the classification of these accessories.
FDA Review Timeline and Decisions
The FDA’s review timeline and decisions regarding Accessory Classification Requests are structured to ensure timely and transparent processes. An Accessory Classification Request may result in either a grant or denial by the FDA.
For an Existing Accessory Classification Request, the FDA commits to making a decision within 85 days of receiving the request. On the other hand, a New Accessory Classification Request is evaluated concurrently with the decision on the associated marketing submission, such as a 510(k) or PMA. This approach streamlines the review process, ensuring that classification decisions align with the overall regulatory approval process for new accessories.
Upon granting an Accessory Classification Request, the FDA will publish a final classification order in the Federal Register. This step serves as public notification of the decision and specifies the classification assigned to the accessory type, promoting transparency and clarity within the medical device industry. In cases where the FDA does not agree with the recommended classification submitted in a request, the submission and associated decision remain confidential. However, the FDA provides a written response to the submitter outlining the basis for denying the request. This ensures that stakeholders receive feedback and understand the rationale behind classification decisions, even in cases of denial.
What Information Should be Included in the Accessory Classification Request?
New Accessory Type
This request must accompany the submission for the primary device and should contain the following elements:
A cover letter that clearly states it is a “New Accessory Request” for a novel accessory type, specifying:
The accessory for which a different classification from the primary device is sought. The proposed classification of the accessory (e.g., class I or class II). Essential information, following the Least Burdensome principles, to establish the risk profile of the accessory when used as intended with the primary device. For requests seeking classification into class II, an initial draft proposal for special controls must be included if such controls would be necessary under subsection 513(a)(1)(B) of the FD&C Act.
Existing Accessory Type
The Accessory Classification Request must contain the following components:
A cover letter that clearly indicates it is an “Existing Accessory Request” for a pre-existing accessory type, specifying:
The accessory or accessories for which a different classification from the primary device is being sought. The current and proposed classification of the accessory or accessories (such as class I or class II). Essential information, following the Least Burdensome principles, to establish the risk profile of the accessory when used as intended with the primary device. If seeking classification into class II, requests must include an initial draft proposal for special controls, provided that special controls would be necessary according to subsection 513(a)(1)(B) of the FD&C Act.
Why Choose us?
When it comes to understanding the complexities of medical device accessories and their classification, we are your trusted partner. Our team of experts is well-versed in the intricacies of the FDA’s regulatory framework and can guide you through the process of submitting an Accessory Classification Request. We understand that each accessory has unique characteristics and intended purposes, and we tailor our approach to meet these specific needs.
Our commitment to following the Least Burdensome principles ensures that we provide you with the most efficient and effective pathway to achieve your goals. We stay updated with the latest changes in technology and regulations, allowing us to provide you with the most current and relevant advice.
About Accel
Accel Groups is a dedicated team of seasoned professionals in regulatory, clinical and market access. We help medical device and IVD manufacturers with complete product life cycle solutions from preclinical, strategy, clinical evaluation and trial, regulatory submission, to post market surveillance. Our regional principals have a minimum of 10+ years’ experience in their specialty to enable us to provide the regional in-depth expertise but with global one-stop shop solutions. Ask us about our Start-up kits for start-up companies with key countries regulatory pathway.
