Medical Devices and 510(k)

A streamlined route to FDA approval or a trap for the unwary?

Advances by medical technology companies provide more efficient patient care and allow affected patients to live longer, more productive lives. Chronic medical conditions that may have resulted in death decades ago are now treatable with devices such as pacemakers and heart valves. Artificial knees and hearing aids improve quality of life for those affected. However, the interplay between the regulatory framework intended to keep patients safe and the patent system intended to provide innovators with market exclusivity may present unforeseen risks to a manufacturer seeking to market a new medical device that is substantially equivalent to an existing device.

The FDA Regulatory Framework and Classes of Medical Devices

Medical devices are subject to review by the Food and Drug Administration (FDA) before they can be marketed and sold. The Federal Food, Drug, and Cosmetic Act (FDCA) defines a medical device such that the FDA regulates a broad range of devices, such as heart valves, tongue depressors and sutures, before and after the devices reach the marketplace.

The three-tier regulatory framework employed by the FDA for medical devices is intended to ensure the safety of new devices while promoting the technological development of the devices. The classifications are assigned by the risk the medical device presents to the patient and the level of regulatory control the FDA determines is needed to market the device:

  • Class I devices – low risk

Class I devices, such as arm slings, elastic bandages and bedpans, generally pose low risk because of their noninvasive nature.

  • Class II devices – moderate risk

Class II devices, such as x-ray systems, surgical drapes, catheters, inflatable blood pressure cuffs and hearing aids, involve moderate safety and efficacy risks.

  • Class III devices – higher risk

Class III devices, such as heart valves and breast implants, are intended for use in supporting or sustaining human life or present a high risk of illness or injury.

In other words, as the risk to the patient increases, so do the classification levels and FDA pre-market scrutiny. For example, before a Class III device may be marketed, it must undergo Pre-Market Approval (PMA) by the FDA and, typically, clinical trials to demonstrate its safety and efficacy. The PMA process is costly and time-consuming, particularly when added to the time and expense required for clinical trials. In comparison, since Class II devices are considered a moderate risk, the FDA reviews these devices for substantial equivalence to legally marketed products that have clearance for the same intended use, referred to as “predicate” devices. The applicant must show substantial equivalence to a predicate device by way of a premarket notification, known as a “510(k),” at least 90 days before bringing the new device to market. A 510(k) must also be submitted for certain Class I devices; however, most Class I devices are exempt from the premarket clearance requirements. The majority of medical devices enter the market via a 510(k).

Understanding the 510(k) process

There are several considerations in the 510(k) submission process.

1. The identification of predicate devices

The 510(k) submission for a new Class II device requires identification of one or more predicate devices to which equivalence is claimed and a substantial equivalence statement. The substantial equivalence statement in a 510(k) is intended to show the FDA that the new device is at least as safe and effective as the predicate devices. To make this showing, a 510(k) includes information on the similarities and/or differences between the new device and the predicate devices, at least in terms of safety and efficacy.

After the 510(k) submission, the FDA has 90 days to make an evaluation of substantial equivalence. Substantial equivalence is generally found if the new device has the same intended use and the same technological characteristics of the predicate device. Indeed, different technological characteristics would likely lead the FDA to find substantial equivalence lacking unless these differences can be shown not to raise new questions of safety and efficacy.

2. The public nature of a 510(k)

Once an applicant submits a 510(k), the documentation generally is publicly accessible through FDA publication and/or a Freedom of Information Act (FOIA) request. The FDA lists the name, manufacturer and the 510(k) summary of all approved devices on its website within a month of approval. The statement of similarities between the new device and the predicate device is also accessible by competitors, including the manufacturer of the very predicate device to which the new device is claimed to be substantially similar.

3. Potential overlap between 510(k) substantial equivalence and patent infringement

The manufacturer of a predicate device is unlikely to allow a substantially equivalent new device to enter the market without exploring available barriers to entry, one of which includes enforcement of a patent that covers the predicate device. As such, the streamlined path to approval of a Class II device by way of a 510(k) may take a costly detour when the predicate device is covered by at least one claim of an existing patent.

At a minimum, the statements made in a 510(k) are available to the predicate device manufacturer to use as a roadmap to allege infringement of a patent claim covering the predicate device. The predicate device manufacturer may also try to use the 510(k) in a more detrimental manner during litigation.

As a threshold matter, a third party may literally infringe a patent claim when making, using, selling or importing any device that has each and every element required by a claim of a patent. There is a likelihood that the new device can be differentiated from at least one of the features of the patent claim to avoid literal infringement. However, if a device performs substantially the same function in substantially the same way to obtain the same result as the patent claim, infringement may be found under patent law’s Doctrine of Equivalents.

Why is this distinction important? Recall that FDA market approval for Class II devices via a 510(k) is more likely when the new device has the same intended use and technological characteristics of the predicate device. As such, it benefits a 510(k) applicant to detail the strong similarities between the features of the new device and the predicate device.

In fact, a seemingly thorough 510(k) may very well outline how the new device performs substantially the same function in substantially the same way to obtain the same result as the predicate device. In such a situation, the substantial equivalence statement submitted in the 510(k) is almost identical to the language used to determine infringement under the Doctrine of Equivalents with one exception: the substantial equivalence in a 510(k) submission to the FDA compares the new device to the predicate device in terms of safety and efficacy whereas substantial equivalence in patent infringement compares the new device to the claims of a patent.

While the courts have indicated that a 510(k) cannot be used by an adversary as an admission of liability of patent infringement, the law is less settled with regard to the role of a 510(k) as supporting material to the claims at issue, such as when an allegation of infringement under the Doctrine of Equivalents is in play. An adversary may try to introduce the 510(k) during litigation to establish a presumption of equivalency between the new device and any patent claim covering the predicate device. This possibility necessitates carefully chosen wording in the 510(k) so it cannot be used during litigation to the detriment of the alleged infringer.