New FDA medical device reforms proposed

On August 3, 2010, the FDA released proposed reforms to the 510(k) premarket notification program. The 510(k) process, used to analyze whether certain medical devices may be marketed in the United States, has come under close scrutiny in recent years as the number of device failures and harms begins to make national news. So it should be no surprise to those in the industry that changes are on the horizon.

Changes to process

The August 3, 2010, report released by the FDA contained numerous proposed changes to the device clearance process, including:

• requiring clinical information, postmarket information, and manufacturing process information of 510(k) applications;
• creating a new class of devices, referred to as class IIb, for which there would be additional requirements;
• updating the de novo review process to address applicants’ use of split predicates and multiple predicates, whereby applicants would be prohibited from using split predicates; and
• considering drafting regulations to address the FDA’s authority to rescind approval of devices, including whether expanded authority is warranted.

The focus of this article will be on the proposed creation of class IIb for devices and the intellectual property implications of the prohibition on split and multiple predicates for devices.

Cydney D. Boler

Crissa Cook

The reforms put forward were the result of a series of internal working group recommendation. One of the key recommendations that is drawing significant fire from the medical device community involves the recommendation that the Center for Device and Radiologic Health (CDRH) explore the possibility of developing guidance to define, as a heuristic, a subset of class II devices called class IIb devices, for which clinical information, manufacturing information, or potentially, additional evaluation in the postmarket setting, would typically be necessary to support a substantial equivalence determination. Delineating between class IIa and class IIb would not reconfigure the current, three-tiered device classification system established by statute; it would represent only an administrative distinction.

Class II with greater risk

The development of a class IIb guidance would provide greater clarity regarding what submitters would generally be expected to provide in their 510(k)s for certain types of devices. Although further deliberation would be needed to better characterize class IIb. Potential candidates for this device subset may include implantable devices, life-sustaining devices, and life-supporting devices, which present greater risks than other class II device types.

Lawrence H. Brenner

B. Sonny Bal

The FDA Working Group found that, in general, most instances where concerns were raised by industry and center staff about problems with the 510(k) program involved the small subset of devices for which staff requested clinical information, either to answer questions appropriate for a substantial equivalence determination, but sometimes in cases where the sponsor had no advance notice that such information would be needed, or to answer questions more appropriate for the de novo classification process. Both scenarios have contributed to less predictability and longer time-to-decision in the 510(k) program. By creating a class IIb-device subset and making appropriate use of a streamlined de novo process, CDRH could make more predictable, timely, and consistent decisions.

Split and multiple predicates

The prohibition on the use of split and multiple predicates also raises questions about whether this effectively forecloses the ability of anyone other than the original device manufacturer — which likely holds patents on the original device — from creating next-generation devices. Previously, a device manufacturer could combine the attributes of two or more approved devices to create a single, nonexistent device, which could then be used as the “predicate device” for the 510(k) decision-making process. In this situation, device manufacturers did not have to make a direct comparison between a single existing (and likely patented) device and the new device for 510(k) approval. However, there has been concern that the use of split or multiple predicates may not allow for a valid comparison of the safety and effectiveness of a proposed device because the predicate device doesn’t actually exist, and there is therefore no real world information about its risks and benefits. This led to the proposed ban on this practice.

Under the new plan, device manufacturers will have to admit a certain degree of similarity to a single, existing device to gain approval. Thus, in the case of patented predicate devices, establishing “substantial equivalence” for the 510(k) approval process may also result in the device manufacturer essentially demonstrating its own infringement of the predicate device.

Further, intentionally designing a new device that is a substantial equivalent of a predicate device to facilitate the 510(k) decision-making process will also give rise to more claims of willful infringement. More specifically, patent holders will necessarily try to use the fact that the new device was designed with the intention of being a substantial equivalent of the patented device for 510(k) approval as evidence of willful infringement. Importantly, willful infringement can result in an infringer paying treble (threefold) damages, which can significantly enhance the costs associated with defending a patent infringement lawsuit.

‘Catch-22’

Accordingly, new device manufacturers are faced with a sort of Catch-22. They either develop a device that is a substantial equivalent to an approved device to facilitate the process of bringing the product to market, but concurrently open themselves up to potentially millions of dollars of liability for patent infringement, with the possibility of paying treble damages for willful infringement. Alternatively, they can design around the patented device to avoid infringement, but also possibly end up with a device different enough from the predicate device that they are precluded from relying on that device for the 510(k) approval process, thereby significantly increasing the costs associated with bringing that product to market.

Thus, although the FDA had safety in mind, the prohibition on the use of split and multiple predicates raises valid concerns about whether it unintentionally undermines the purpose of predicate devices in the approval process (for everyone except for the original device manufacturer) in the first place.

Each of the proposed regulation changes prompted by the working groups is designed to make the agency more nimble and transparent. Another stated goal of the impending regulatory changes is, of course, safety. With each proposed change, device manufacturers and users of medical devices must be sure to keep a watchful eye on the alterations stirring within the FDA. With more pressure than ever on this agency to be more responsive and yet more all-encompassing there are bound to be more requirements coming in the way the devices are approved and the way they are monitored. Additionally, as developers of technology in this area, manufacturers and inventors need to be mindful of the intellectual property aspects of bringing new devices to market.

It is debatable whether the diverse proposals released by CDRH will adequately answer and correct the specific mistakes, procedural failures, and programmatic deficiencies raised in the agency’s 2009 internal review of the Menaflex 510(k) clearance. Moreover, the proposals may address — but are not specifically focused on — the many issues raised during recent congressional oversight of novel diagnostics and the FDA’s controversial draft guidance on In Vitro Diagnostic Multivariate Index Assays (IVDMIAs), suggesting that many questions unique to advanced molecular diagnostics, laboratory developed tests (LDTs), and CDRH’s Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) will receive further scrutiny.

Finally, in addition to innovative companies, regulated industry, and patient advocates, Congress is a key audience of CDRH’s proposals, given the impending reauthorization of medical device user fees under the Medical Device User Fee and Modernization Act (MDUFMA) by September, 2012. Stakeholders should anticipate continued congressional scrutiny of the rigor and efficiency of FDA’s medical device regulation, particularly in light of President Obama’s recent focus on regulatory reforms to “make our economy stronger and more competitive” as well as CDRH’s own claims that its reforms will suffice to “keep the United States the leader in medical device innovation.” As changes become codified we will bring you those updates.

• Cydney D. Boler is special counsel with Foulston Siefkin LLP.
• Crissa Cook is an associate at Hovey Williams LLP.
• B. Sonny Bal, MD, JD, MBA, is associate professor of hip and knee replacement in the department of orthopedic surgery, University of Missouri School of Medicine.
• Lawrence H. Brenner, JD, is on the faculties of orthopedics at Yale University and the University of Southern California and practices in Chapel Hill, N.C. Address all correspondence to Brenner at lb@lawrencebrennerlaw.com.