The U.S. Food and Drug Administration's (FDA) recently released draft guidance, Medical Device Accessories: Defining Accessories and Classification Pathway for New Accessory Types (January 20, 2015), presents a sensible approach to classifying medical device accessories. A more accurate title for this guidance might be Medical Device Accessories: Defining Accessories and New Classification Pathway for Accessories, because FDA recommends using the de novo process for classifying an accessory based on the risk(s) associated with its intended use, independent of the parent device classification. This guidance only applies to "new accessory types," meaning those accessories that have not been previously approved via a premarket approval ("PMA") or are not already classified by regulation or order. Reclassification or exemptions may be sought for existing accessories. Let's examine the significance of this draft guidance on Class II and Class III medical device manufacturers of new accessory types.
A Little History
FDA regulates accessories because they are considered medical devices under Section 210(h) of the Food, Drug, and Cosmetics Act. Historically, a medical device accessory has been assigned the same classification as its parent device; exceptions were those accessories which could be used with multiple parent devices or had unique standalone features. As might be expected, this led to a plethora of low-risk accessories being classified as Class III, resulting in a regulatory burden on manufacturers that was not commensurate with risk.
An Expensive 'Clothespin'
In the new guidance, FDA is talking about an accessory as something used to support, augment or supplement the use of a device. For example, let's consider a small 'clothespin' that is offered as a user convenience item for a Class III catheter. The clothespin was designed to hold the catheter in a loop on a preparation table to prevent the catheter from springing off the table and onto the floor. Since the catheter was classified by FDA as a Class III product, and the clothespin was designed specifically for use with the catheter, then the clothespin was also regulated by FDA as a Class III product based merely on the parent device classification. Therefore, all the requirements of a Class III approval, such as reporting minor design or manufacturing changes in a PMA Supplement applied to the clothespin even though the clothespin played no part in actual use of the catheter. This was one highly regulated clothespin!
If the clothespin were being submitted today, it likely would be exempt or Class I, according to the new draft guidance, which is a far more appropriate classification based on its risk when used as intended with the parent device. The guidance removes both burden and cost for medical device manufacturers and certainly lessens burden for the FDA with respect to management of design or manufacturing changes – a true win-win for both sides.
A New Pathway
In the draft guidance, FDA suggests manufacturers use the de novo process as a pathway for Class I or Class II classification for new accessories for which there is no predicate. The draft guidance offers suggestions regarding the type of information manufacturers should include in an accessory de novo submission. The clearance of a Class II new accessory blazes a new pathway forward for other manufacturers to use the accessory as a predicate and file a 510(k) instead of submitting a de novo classification request first. The cumulative effect of the new draft guidance results in lower initial and ongoing regulatory compliance costs for manufacturers and less oversight effort from FDA, allowing the FDA to shift its focus to higher risk issues.
This draft guidance represents a quantum leap forward in the practical application of device regulation, and we applaud the FDA in its effort to unburden the system... or at least significantly lighten the load. But what could really turn this guidance from a home run into a grand slam is inclusion of guidance for existing accessory devices. Perhaps during the 90-day comment period, device manufacturers and interested parties will voice their collective support for expansion of this guidance into a fully comprehensive guidance that not only addresses the future, but present accessories as well.