510(k) Exemption – What’s Actually Exempt?

FDA generated a great deal of the buzz a few weeks ago when it proposed exempting more than 1,000 Class II devices from the 510(k) requirements (see our earlier post here). Given the excitement, we thought it might be worth discussing what devices are no longer subject to the 510(k) requirements when a generic device type becomes 510(k)-exempt.

FDA classifies devices into Class I, II, and III. There are specific classification regulations associated with each generic type of device. The classification regulations can, however, cover a broad category of devices (e.g., manual surgical instruments). In order to create additional granularity with regard to device technology within each classification regulation, FDA created product codes. There can be one or many product codes within a classification regulation.

FDA’s analysis of whether to exempt a type of device from the 510(k) requirements is specific to the devices within the generic category in question. Thus, FDA does not always propose exempting all product codes within a classification regulation. In addition, FDA sometimes places limitations (e.g., type of technology or indications for use) on an exemption within a classification regulation.

When a generic type of product (often identified by its product code within a classification regulation) becomes exempt from the 510(k) requirements, future products of that generic type will not be required to obtain 510(k) clearance prior to marketing – but, the exemption is subject to the .9 limitations. Each classification regulation part (21 C.F.R. Parts 862 – 892) includes a .9 section (e.g., 21 C.F.R. § 862.9). This section is often overlooked for the more substantive, device-specific sections later in the Part. However, the .9 limitation is crucial in understanding what is and is not 510(k)-exempt.

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” at the time the generic type of device became exempt from the 510(k) requirements. The .9 regulation elaborates on what this phrase means by way of examples. Specifically, a 510(k) is required if the proposed device:

1. has a “different” intended use as compared to the generic device type; or
2. uses a different “fundamental scientific technology” compared to the generic device type.

Note: there are other additional .9 limitations specific to in vitro diagnostic devices, which we are not discussing here.

Determining whether or not a device’s characteristics (i.e., fundamental technology and intended use) were foreseeable at the time of the exemption is not an easy task, and is rather subjective. Certainly the technology and intended use described in the classification regulation are existing and foreseeable. Beyond the classification regulation, 510(k) clearances already in place at the time of an exemption can shape whether an intended use or technology are considered reasonably foreseeable. See 63 Fed. Reg. 59222, 59224 (Nov. 3, 1998) (here).

Clearances that are granted after an exemption is finalized are also useful information. These post-exemption clearances provide insight into the types of changes that FDA concluded exceeded the limitations in a .9 regulation. Once a specific device is deemed to trip the .9 limitation and must undergo 510(k) review, similar devices must also undergo 510(k) review.

If there are no pre- or post-exemption 510(k) clearances that obviously answer the question whether a proposed device is exempt or not, a manufacturer will need to analyze the need for a 510(k) more generally based upon the intended use and fundamental scientific technology prongs, described above. With regard to intended use, as described in the .9 regulation, the bar is quite high – a different intended use, including a new medical purpose or changing the user population (e.g., from professionals to lay users). However, FDA has analogized this prong of the analysis to the standard for determining if a new 510(k) is required, as set out in its 1997 Blue Book Memorandum, “Deciding When to Submit a 510(k) for a Change to an Existing Device.” See 63 Fed. Reg. 59224. Thus, although the standard may appear high, generally, from FDA’s perspective, even modest changes to the indications for use could trip the exemption.

Fundamental scientific technology on its face appears to be a very high standard – essentially a completely different technological means of achieving the same end goal. The specific examples cited in the .9 regulations support this being a high standard. These examples are a surgical instrument that cuts tissue with a laser beam rather than with a sharpened metal blade and an in vitro diagnostic assay that uses a DNA probe or hybridization rather than traditional immunoassay. These are significant changes. Thus, manufacturers can generally iterate and evolve from a technological perspective and still fall within a 510(k) exemption. A manufacturer should analyze the proposed technological features of a device compared to the technological features within the exemption to determine whether or not the proposed device trips this prong of the exemption.

The most recent list of proposed 510(k) exemptions is set to be finalized this July. When the list is finalized, there are certain to be at least a few 510(k)s pending for devices within the scope of the exemption. In the past, FDA has advised manufacturers that a 510(k) submission pending when an exemption is finalized should be withdrawn. 63 Fed. Reg. 3142, 3143 (Jan. 21, 1998) (here). FDA has not reiterated that guidance more recently.

Anyone with a submission pending when an exemption is proposed, should discuss with the lead 510(k) reviewer whether the submission should be withdrawn – meaning it falls within the exemption – or whether it should proceed – meaning that it falls outside the exemption.