Recent Developments Relating to 513(g) Requests for Classification

It is not uncommon for the classification of a particular product, and thus, the regulatory status of that product under the medical device regulations, to be unclear.  Indeed, the medical device classification scheme, established in 1976, was not intended to capture every possible iteration or potential offshoot of existing medical devices, nor could the regulations be expected to capture the extent of future device innovations.  To that end, the Federal Food, Drug, and Cosmetic Act (“FDCA” or the “Act”) provides a mechanism by which a person may seek advice from the U.S. Food and Drug Administration (“FDA” or “the agency”) about the specific classification of a medical device.  Section 513(g) of the Act provides:

Within sixty days of the receipt of a written request of any person for information respecting the class in which a device has been classified or the requirements applicable to a device under this Act, the Secretary shall provide such person a written statement of the classification (if any) of such device and the requirements of this Act applicable to the device.(1)

Over the years, companies have relied on Section 513(g) to file written requests, referred to as 513(g) requests, at no cost, to obtain a statement as to the classification of their product, such as whether the product is regulated as a medical device, whether the product is 510(k)-exempt, or whether FDA would require a 510(k) premarket notification or premarket approval for a particular device.  It has widely been understood that FDA’s advice in response to the information set forth in a 513(g) request was binding as an advisory opinion, unless amended or revoked by the agency.(2)  

Since implementation of the FDA Modernization Act of 1997 (“FDAMA”) and the Medical Device User Fee and Modernization Act (“MDUFMA”) of 2002, the agency has observed a significant increase in the number of 513(g) requests. In 2000, the agency received a total of 69 513(g) requests.(3)   By 2007, that number had increased to almost 400 per year.(4)   FDA has attributed this marked increase, in part, to the establishment of user fees for a number of premarket submissions, including 510(k) premarket notifications.(5)   However, with enactment of the FDA Amendments Act of 2007 (“FDAAA”), 513(g) requests are now subject to user fees as well.  The standard filing fee for 513(g) requests for fiscal year (“FY”) 2008 is $2,498.00 and the discounted fee for small businesses is $1,249.00.(6)   Notably, these fees are not much less than the user fees for 510(k) premarket notifications, where the standard user fee is $3,404.00, and the discounted fee for small businesses is $1,702.00. 

In addition to the implications of an associated user fee for such request, FDA is cautioning device manufacturers to think twice before filing 513(g) request.  The agency is taking the position that the majority of 513(g) requests are unnecessary and that responses to 513(g) requests are non-binding, voluntary opinion letters.(7)   In light of this position, agency staffers have been advocating the use of informal phone calls or the filing of a 510(k) premarket notification to answer classification questions, while highlighting the newly established user fee for 513(g) requests as another reason to reconsider.(8)  

The agency has announced that it is currently drafting two guidance documents to help clarify the role of 513(g) requests for classification.   In the mean time, due to the new user fee associated with 513(g)s, as well as recent statements concerning the non-binding nature of the agency’s advice in response to a 510(k) request, companies may need to assess the use of 513(g) requests as part of their overall regulatory strategies.