510(k) Exemption – What’s Actually Exempt Part II

Our April 16^th blog post regarding 510(k) exemptions (here) garnered a lot of comments from our readers. So we thought it was worth a second post.

As you will recall, the .9 limitation says that a device of the generic type in a 510(k)‑exempt classification regulation is exempt so long as its characteristics were “existing and reasonably foreseeable” as compared to the generic type of device subject to the exemption. The regulation elaborates on what this phrase means by way of examples. Our original post covered the two main examples – intended use and fundamental scientific technology – applicable to all devices. In our original post, we explained that 510(k) clearances occurring prior to issuance of a 510(k) exemption for a category of devices can shape whether a new device’s characteristics are considered “existing and reasonably foreseeable.” This position has been acknowledged by FDA. See 63 Fed. Reg. 59222, 59224 (Nov. 3, 1998) (here).

We also indicated that post-exemption 510(k) clearances set the bounds of devices that fall outside the exemption and similar devices would also require 510(k) clearance prior to marketing. Based on our research, FDA has not articulated an official position as to what (if any) affect a post-exemption clearance has on the scope of a 510(k). Absent an interpretation from FDA, we performed our own analysis. The .9 regulations indicate that a 510(k) exemption applies to a new device in an exemption category, “to the extent that the device has existing or reasonably foreseeable characteristics of commercially distributed devices within that generic type.” The .9 regulations do not state when the characteristics of the exempt category were set or if they can change over time. It seemed reasonable to us that the characteristics must have been reasonably foreseeable at the time of the 510(k) exemption. If a type of device falls outside the exemption, it would require a 510(k) clearance. It did not seem to us that FDA would likely agree that such a 510(k) would modify the foreseeability of a subsequent device’s characteristics as it related to the exemption. Thus, if a device’s characteristics were not foreseeable, a future device with similar characteristics would also not be foreseeable as it relates to the exemption.

As stated above, based on our prior research, we have not identified any official statement from FDA regarding the effect of post-exemption clearances on the scope of the 510(k) exemption. In an effort to get some sort of an answer, we reached out to the 510(k) Premarket Notification Section within the Office of Device Evaluation. Last week, we received the following response:

When a company submits a 510(k) for a device under a 510(k) exempt regulation, it is because the device exceeded the limitations of exemption for that regulation.  If the device is then found substantially equivalent, the technology and/or indications newly cleared within that 510(k) would then expand the limitations of exemption within that regulation.

This response clearly articulates that a post‑exemption 510(k) clearance permanently adds to or broadens the scope of a 510(k) exemption. In the recent past, we have received responses to this same question from other Office of Device Evaluation (ODE) officials that have been either contrary to the above position or less clear. None of this correspondence “between representatives of FDA and an interested person outside FDA on a matter within the jurisdiction of the laws administered by [FDA],” is likely to be considered final agency action subject to judicial review. 21 C.F.R. § 10.65(a). Nonetheless, the response above is unambiguous and it does come from an office that is located within the Office of the ODE Director, so it seems to us reasonably definitive.

It is noteworthy that the foregoing position could lead to a competitive disadvantage for companies filing a 510(k) for a device believed to trip the .9 limitation. Competitors looking to enter the market after a post-exemption clearance will be able to enter the market immediately, because the clearance expanded the scope of the exemption. The company that obtains a post-exemption clearance must do all the work to expand it. The second comers will not have to do anything from a premarket perspective. This approach could deter companies from obtaining post-clearance exemptions, and some may wait until they receive an untitled or warning letter from FDA indicating that they must do so.

A reader also requested that we address the IVD-specific limitations in the .9 regulations. IVDs are subject to the same general limitation that its characteristics must be “existing and reasonably foreseeable” at the time the generic type of device became exempt from the 510(k) requirements. In addition to the intended uses and fundamental scientific technology examples, the .9 regulations also include a number of IVD specific examples for when the .9 limitations are tripped. Specifically, a 510(k) is required if the proposed device is intended:

• For use in the diagnosis, monitoring, or screening of neoplastic diseases with the exception of immunohistochemical devices;

• For use in screening or diagnosis of familial or acquired genetic disorders, including inborn errors of metabolism;

• For measuring an analyte that serves as a surrogate marker for screening, diagnosis, or monitoring life-threatening diseases such as acquired immune deficiency syndrome (AIDS), chronic or active hepatitis, tuberculosis, or myocardial infarction or to monitor therapy;

• For assessing the risk of cardiovascular diseases;

• For use in diabetes management;

• For identifying or inferring the identity of a microorganism directly from clinical material;

• For detection of antibodies to microorganisms other than immunoglobulin G (IgG) or IgG assays when the results are not qualitative, or are used to determine immunity, or the assay is intended for use in matrices other than serum or plasma;

• For noninvasive testing as defined in 812.3(k) of this chapter; and

• For near patient testing (point of care).

These examples are much more specific than the broad intended use and fundamental scientific technology examples. In addition, they are additive to the other two examples for IVD companies looking to take advantage of a 510(k) exemption. Thus, IVD manufacturers should be aware of these examples and ensure that a new IVD potentially fitting within a 510(k)-exempt category does not trip the .9 exemption for any of these reasons.