By Allyson B. Mullen –
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. For example, does a filter in suction device, when sold separately from the suction device by a third party, carry the same risk as the suction device supporting a Class II designation? Possibly not. Similarly, software used with a traditional device was generally considered an accessory to the device. However, depending on the software’s function, it could (and in many instances does) present much less risk than the parent device.
With regard to accessories that were separately classified, these accessories were presumably classified based on the risk that they present, separately from the parent device. These classification regulations typically classified the accessory as lower risk than the device. For example, Endosseous dental implant accessories are Class I devices whereas Endosseous dental implants are Class II devices. 21 C.F.R. §§ 872.3980 and 872.3640.
In practice, however, FDA did not always utilize the appropriate accessory classification regulation when it existed, leading to some accessories being classified under the higher, parent device classification regulation. For example, powered wheelchairs, wheelchair accessories, and wheelchair components each have their own separate classification regulation, all of which were promulgated at the same time in 1983. 21 C.F.R. §§ 890.3860, 890.3910, and 890.3920. The finished powered wheelchairs are classified as Class II devices and the accessories and components are classified as Class I devices (for purposes of this post, we are ignoring the fact that FDA classified a component but did not exempt it from the QSR – that is a post for another day). Because of this classification framework, one might expect that 510(k)s cleared under the powered wheelchair classification regulation would be limited to finished wheelchairs only, after all there are separate, specific classification regulations for wheelchair components and wheelchair accessories. However, there are numerous Class II 510(k) clearances for powered wheelchair components/accessories under the powered wheelchair classification regulation.
In short, FDA’s scheme for classifying accessories led to some accessories being over-regulated because they are not as risky as the parent device (but they were classified according to the parent device), or a somewhat confusing scheme of certain accessories having their own classification but a subset of those accessories being classified under the parent device classification.
FDA sought to resolve this issue for new types of accessories (i.e., accessories not previously classified according to one of the methods described above) in January 2015 when it released the draft guidance “Medical Device Accessories – Defining Accessories and Classification Pathway for New Accessory Types” (see our earlier post here). The draft guidance acknowledged that some accessories present less risk than the parent device with which they are used and do not, accordingly, need to be placed in the same class as the parent device. The draft guidance proposed that sponsors should 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 de novo process would allow for the risk-based classification of the new accessory type on its own.
Almost two years after FDA’s release of the draft guidance, Congress, apparently agreeing with FDA’s proposal in this draft guidance, passed the 21st Century Cures Act (Cures) amending Section 513(b) of the Federal Food, Drug, and Cosmetic Act (FDCA) which directed 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 draft guidance document with virtually no changes, a mere 17 days after Congress’s change to the law (see our earlier post here).
Congress’s directive in Cures was new – classify devices based on their risk independent of the parent device. FDA’s draft and final guidances also only addressed new types of accessories. Thus, neither Congress nor FDA addressed the potentially over-regulated accessories or accessories with confusing regulatory schemes that were classified prior to passage of Cures. It appears that 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.
FDA was well aware of the issues surrounding previously classified accessories because nearly every comment that the Agency received regarding the draft accessory guidance in early 2015 specifically raised this issue. FDA received thirteen individual comments regarding this draft guidance – admittedly not a huge number – but the vast majority of them all said the same thing. Commenters indicated that there should be a mechanism to reclassify existing devices (note: some commenters appeared to have mistakenly believed that the de novo process could be used to reclassify existing devices and therefore discussed the disadvantages of the de novo process as it related to existing devices).
In addition, many commenters also stated that the de novo process is an onerous process that may be unduly burdensome for low-risk accessories. Moreover, one manufacturer would need to go through the de novo process, at its own time and expense, to establish a low-risk classification for a new accessory type and then, assuming that the accessory was exempt from most regulatory requirements, all other manufacturers of the same accessory type would benefit.
A new piece of legislation released last week seeks to address previously classified accessories and also create a new, less burdensome regulatory pathway for classification of low risk accessories. The Bill, H.R. 2144, entitled “Risk-Based Classification of Accessories Act of 2017,” was introduced in the House by Representative Mimi Walters of California. For new types of accessories, when a manufacturer files a premarket submission for the parent device, it can also submit a recommendation for an appropriate, risk-based classification of any related accessories, if applicable (note: in some instances the accessory should carry the same classification as the parent device and in that case no such separate classification would be appropriate). The Agency will review and classify both the parent device and the accessory appropriately as part of its premarket review. This change in the law would be helpful to manufacturers of parent devices who wish to submit a single submission for a parent device and its accessories. Under the current regulatory framework, a 510(k) clearance or PMA approval results in a single classification determination for all devices/accessories included within that submission.
With respect to accessories that were classified prior to Cures (e.g., through 510(k) clearance or PMA approval with a parent device), a manufacturer may submit an application proposing an alternative, appropriate, risk-based classification for an accessory (presumably lower than its current classification). The application must include information to support the recommended classification. FDA would have 60 days to review and decide on such an application; however, before making a final decision the manufacturer would be given an opportunity to meet with appropriate FDA personnel regarding the proposed reclassification.
In our view, this proposal would provide a reasonable process for reclassification of existing accessories, which may be over-regulated. This process could also allow accessories with confusing regulatory schemes (i.e., a specific accessory classification regulation but some accessories cleared under the parent device’s classification) to be easily clarified by allowing for reclassification into a more appropriate, existing accessory classification regulation. As discussed above, there is currently no good means by which industry (or FDA) can undertake either of these activities. We will certainly keep our readers updated on any future developments related to this Bill.
Proposed Legislation Seeks to Further Address the Issue of Classifying Device Accessories
By Allyson B. Mullen –