On December 20, FDA issued a new, draft guidance, “Medical Device Accessories – Describing Accessories and Classification Pathways.” This guidance is the latest chapter in the years-long, and still on-going, story of accessory classification. As you may recall, Congress and FDA have both been working for years to revamp how accessories are classified. The 21st Century Cures Act (Cures Act), signed into law in December 2016, required that accessories be independently classified from the parent device. The Food and Drug Administration Reauthorization Act (FDARA), signed into law in August 2017, went a step further, specifying a process for such classification and re-classification or accessories previously classified based on the parent device with which it is used.
It is impressive that after a mere four months, FDA has issued a draft guidance that complies with the new statutory provision. Below, we provide historical perspective on why the accessory classification process needed changing as well as commentary on the draft guidance.
In short, the guidance is a clear restatement of the statutory requirement and lays out a good framework on which industry can comment. In our view, additional clarification and details, beyond the statutory requirements, should be included in the final guidance.
As we have previously discussed in our earlier posts (here, here, and here) regarding the Agency’s classification of accessories, FDA has historically classified accessories in one of two ways: (1) according to the parent device’s classification (either by express inclusion in the classification regulation or by clearance or approval of an accessory under the parent device’s classification regulation); or (2) by establishment of a separate classification regulation specific to the accessory type. This classification scheme led to a number of issues. With regard to accessories classified according to the parent device’s classification were, in at least some instances, being over-regulated.
The Cures Act and FDA’s 2016 Guidance
The Cures Act has a provision directing the Agency to “classify an accessory . . . based on the intended use of the accessory, notwithstanding the classification of any other device with which such accessory is intended to be used.” FDA finalized the guidance, “Medical Device Accessories – Describing Accessories and Classification Pathway for New Accessory Types,” later in the same month that the Cures Act was passed. (2016 Guidance)
The 2016 Guidance acknowledged that some accessories present less risk than the parent device with which they are used and should not, accordingly, be automatically placed in the same class as the parent device. The 2016 Guidance recommended that sponsors utilize the de novo process for new types of accessories (i.e., not yet classified) for which the risk is less than the parent device.
The Cures Act and the 2016 Guidance only addressed new, not yet classified, accessories. Neither addressed the large body of accessories classified prior to passage of the Cures Act. The only option for reclassification of these accessories would be to submit a petition for reclassification under 21 C.F.R. § 860.123. Petitions for reclassification are seldom used and the Agency is typically slow to respond.
FDARA and FDA’s 2017 Draft Guidance
FDARA, in part, sought to solve this problem of previously classified accessories. FDARA established an 85-day process for re-classifying accessories based on their risk, separate from the parent device with which they are used. This is a new submission type not previously implemented at FDA. In addition, for accessories previously classified according to the parent device with which they are used, by August 2018, and at least once every 5 years thereafter, FDA is now required to publish a list of accessories that it determines are suitable for classification into Class I.
FDARA also created a new streamlined process for classifying new accessories separately from, but concurrently with the parent device. For accessories not previously classified, when a sponsor submits a 510(k) or PMA for a parent device with an accessory, the sponsor may include a request for classification of the accessory based on its risk. FDA’s clearance or approval letter shall include a granting or denial for the sponsor’s request.
The 2017 draft guidance indicates how FDA will implement the revised statutory provisions in FDARA. Specifically, Section VI of the guidance reiterates the two new accessory classification request pathways created by FDARA. FDA plans to track both types of requests as pre-submissions. While pre-submissions by their nature are non-binding, it appears this will simply be for tracking purposes because the output of an accessory classification request will be a classification order. Administratively, it is not clear how this will work. At a minimum, under the statute, FDA has authority to issue a classification order in response to an accessory classification request. We assume this order will be published in the Federal Register, like administrative classification and reclassification orders permitted under FDASIA. However, the timing for issuance of the public order is unclear. Pre-Submissions are generally non-public, unlike other premarket submissions, the output of which are made public on FDA’s website. However, the output of this new type of Pre-Submission will be important to both the applicant as well as the general public. We hope that the final guidance provides additional clarity regarding how and when it will make publicly available the output of accessory classification requests that are done solely through the pre-submission process.
The guidance also strongly recommends that manufacturers submit a pre-submission prior to seeking reclassification or classification of an accessory through either of the new pathways. Yes, you read that correctly, a pre-submission to a pre-submission. Everyone loves the pre-submission program!
With regard to reclassification of accessories previously classified under a parent device’s classification, applicants can submit an “Accessory Request” for reclassification under a lower regulatory classification. The draft guidance provides very high level recommendations as to the type of information that should be included in such a request. FDA has 85 days from receiving an Accessory Request in which to review and approve or deny it, as required by statute.
With regard to new accessories, an applicant can submit a request for classification together with a premarket submission (e.g., 510(k), PMA, de novo) for the parent device for which the accessory is intended for use (a “New Accessory Classification”). The classification request would identify a lower classification than the classification of the parent device under review. For example, a classification request in a PMA might explain why an accessory used with the parent device that is the subject of the PMA is appropriately classified as Class I or II. The draft guidance provides very high level recommendations as to the type of information that should be included in such a classification request. FDA will grant or deny the classification request when it clears or approves the premarket submission. If the request is denied, the accessory will be considered cleared or approved with the parent device in its same classification.
Because the request must be submitted with the parent device’s premarket submission, it appears this process will only benefit accessories owned or manufactured by the parent device company or those accessory manufacturers with a cooperative relationship with the parent-device manufacturer. Manufacturers of new accessories that do not have a relationship with the parent device manufacturer may utilize the de novo process to seek classification of their accessories. This may sound like a minor procedural difference; however, there are no user fees associated with the classification request included with the parent device submission and the de novo user fee is $93,229 ($23,307 for a small business). Thus, there is a significant financial savings by submitting for classification as part of the parent device submission and potentially more expeditious (MDUFA goal of 150 days for a de novo as compared to 90 days for a 510(k) or 180 days for a PMA). It is unclear as to how difficult the burden of each submission will be because the 2017 draft guidance does not provide great insight into the type of information necessary to support a classification request.
One important clarification that will be needed for the New Accessory Classification requests is what constitutes “the parent device submission.” Does it mean the first time a parent device is submitted to FDA (e.g., an original PMA or 510(k)) or could it be a change to an existing device (e.g., a PMA supplement or Special 510(k))? If it is the latter, a PMA Supplement that proposes a Class I or Class II classification for a new accessory or a Traditional or Special 510(k) for a Class I accessory would be far less expensive than a de novo. We think it would be advisable for FDA to clarify this point in their final guidance. If New Accessory Classification requests can be submitted as changes to a cleared/approved device, accessory manufacturers may seek out relationships with the parent-device manufacturer in order to be able to take advantage of this cost savings. Such a relationship may also streamline the process for generating data to support such a submission.
There are two other notable changes in the new draft guidance. First, the draft guidance expressly states that it applies to all accessories, whether required or optional. In addition, the guidance expressly applies to software accessories. These points arguably were implied in the 2016 guidance, but it is nice that they are now expressly stated.
The draft guidance has a detailed appendix regarding the type of information to be included in a de novo application for a new accessory. It would also be helpful for FDA to consider including appendices detailing the types of information that should be included in a classification request as part of a parent device submission and a reclassification request.
In sum, we think this is a good draft, which closely follows the statutory requirements for the new program. However, additional details should be added before the final guidance is issued to make it more useful for both industry and FDA.