• FDA Taking Comments on Potential New Hurdles for Approval of Medical Devices
  • September 16, 2011 | Authors: Robert "Rob" E. Browne; John F. Costello; Matthew M. Morrissey
  • Law Firm: Troutman Sanders LLP - Chicago Office
  • The recent furor in the medical device industry over a new recommendation that the U.S. Food & Drug Administration abandon its approval process for medical devices has prompted a new round of public meetings and comment. This provides a critical opportunity for the medical device industry to comment on these potential new hurdles to market entry.

    The recommendation from the Institute of Medicine was in response to being asked for suggestions for the FDA’s 510(k) approval process for medical devices. Needless to say, the Institute of Medicine’s report drew instant criticism from participants in the medical device industry and predictions that time to market and costs will increase.

    In reaction, the FDA has announced it will hold a public meeting on September 16, 2011, to discuss the Institute of Medicine’s report, as well as open a public docket to receive comments from the public and the medical device industry through September 30, 2011.

    FDA Premarket Review of Medical Devices

    With the exception of certain lower-risk devices that are exempt from premarket review, the FDA reviews the safety and effectiveness of medical devices for their intended use prior to marketing. Medical devices are grouped into three classes on the basis of the risks posed and the ability of post-market controls to manage those risks.

    For devices deemed to be high-risk, classified as Class III, the FDA review and approval is done under the premarket approval (PMA) process, in which each manufacturer must independently demonstrate reasonable assurance of the safety and effectiveness of its device for its intended use. A significant number of medical devices are cleared for health care use by the FDA through a simpler process known as premarket notification, or the 510(k) clearance process. Devices deemed to be moderate-risk, classified as Class II, can be cleared through the 510(k) process, in which the FDA will clear a new device if it finds, through review of a 510(k) submission, that the device is substantially equivalent to a predicate device on the market.

    The 510(k) process is a major component of the FDA’s premarket review of medical devices, with more than 99 percent of all medical devices cleared through the 510(k) process, compared to less than 1 percent approved through the PMA process.

    FDA Requests Analysis of 510(k) Process From the Institute of Medicine

    The 510(k) process, as it currently exists, is intended to support the FDA’s public health mission by meeting two important goals: (1) providing consumers with devices that are safe and effective and (2) fostering innovation in the medical device industry. Recently, high-profile incidents and concerns about changes in technology outpacing regulators have been raised.

    In response, the FDA undertook a two-pronged assessment of the 510(k) clearance process. First, the FDA convened an internal working group, which issued a report in August 2010. The FDA internal working group report contained a number of findings and recommendations, emphasizing that “[t]he recommendations contained in this report are preliminary [and] FDA has not made any decisions on specific changes to pursue.” Notable recommendations include the following:

    • Center for Devices and Radiological Health (CDRH) more clearly define the term “substantial equivance.”
    • CDRH to issue guidance to set forth factors regarding when a device should not be used as a predicate.
    • CDRH streamline the Evaluation of Automatic Class III Designation process, also known as the de novo classification process.
    • CDRH explore creation of a subset  of Class II devices, delineating between Class IIa and Class IIb, with the latter to potentially include implantable devices, life-sustaining devices and life-supporting devices that present greater risks than other Class II devices.
    • CDRH to enhance its internal and external 510(k) databases to include additional information on predicate devices and prior 510(k) decisions.

    Second, the FDA commissioned an independent study of the 510(k) clearance process by the Institute of Medicine. The intent of the FDA when it commissioned the report was to have the Institute of Medicine review the 510(k) process and answer two questions:

    1. Does the current 510(k) clearance process protect patients optimally and promote innovation in support of public health?

    2. If not, what legislative, regulatory, or administrative changes are recommended to achieve the goals of the 510(k) clearance process optimally?

    The answers the FDA received in response were a recommendation to abandon the 510(k) process and a statement that more research was needed before the second question could be answered.

    Institute of Medicine’s Report on FDA’s 510(k) Process

    Interestingly, the Institute of Medicine did not directly answer the questions posed by the FDA. Instead, the Institute of Medicine articulated a number of criticisms of the FDA’s medical device review process.

    These criticisms are contained in a report titled Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years, which concluded that the 510(k) clearance process is not intended to evaluate the safety and effectiveness of medical devices. The Institute of Medicine made the following recommendations about device regulations in general:

    • Recommendation 7-1 The Food and Drug Administration should obtain adequate information to inform the design of a new medical-device regulatory framework for Class II devices so that the current 510(k) process, in which the standard for clearance is substantial equivalence to previously cleared devices, can be replaced with an integrated premarket and post-market regulatory framework that effectively provides a reasonable assurance of safety and effectiveness throughout the device life cycle. Once adequate information is available to design an appropriate medical-device regulatory framework, Congress should enact legislation to do so.
    • Recommendation 7-2 The Food and Drug Administration should develop and implement a comprehensive strategy to collect, analyze and act on medical-device post-market performance information.
    • Recommendation 7-3 The Food and Drug Administration should review its post-market regulatory authorities for medical devices to identify existing limitations on their use and to determine how the limitations can be addressed.
    • Recommendation 7-4 The Food and Drug Administration should investigate the viability of a modified de novo process.
    • Recommendation 7-5 The Food and Drug Administration should develop and implement a program of continuous quality-improvement to track regulatory decisions on medical devices, identify potential process improvements in the medical device regulatory framework, and address emerging issues that affect decision-making.
    • Recommendation 7-6 The Food and Drug Administration should commission an assessment to determine the effect of its regulatory process for Class II devices on facilitating or inhibiting innovation in the medical-device industry.
    • Recommendation 7-7 The Food and Drug Administration should develop procedures that ensure the safety and effectiveness of software used in devices, software used as devices, and software used as a tool in producing devices.
    • Recommendation 7-8 The Food and Drug Administration should promptly call for PMA applications for or reclassify Class III devices that remain eligible for 510(k) clearance.

    Specifically, the Institute of Medicine stated: “[t]he committee does not believe that further investment in the 510(k) process is a wise use of the FDA’s scarce resources and ... FDA’s resources would be put to better use in obtaining information needed to develop a new regulatory framework for Class II medical devices and addressing problems with other components of the medical-device regulatory framework.”

    The report stated that “the FDA’s role in facilitating innovation in Class II medical devices through premarket review should be to create a regulatory framework that sets appropriate thresholds for bringing products to the market ... [, which] should be stringent enough to satisfy the agency’s objective of ensuring that marketed medical devices will be safe and effective throughout their life cycles but realistic enough to permit timely entry of new devices that may offer improvements over already marketed devices.” The report also called for FDA to reclassify Class III devices that remain eligible for the 510(k) process or require such devices to undergo the PMA process.

    Concerning all medical device classifications, the report recommended that the FDA develop and implement a comprehensive strategy to collect, analyze, and act on medical device post-market performance information. The report also recommended that the FDA review its regulatory enforcement authority to identify any limitations and determine how such limitations, if any, can be addressed.

    In light of the profound impacts the report could have on the medical device approval process, it is critical for the medical device industry to participate in the comment process, which is scheduled to close on September 30, 2011. This also presents a unique opportunity to again comment on FDA’s internal working group report.

    Questions Raised by the Institute of Medicine's Report

    Needless to say, the prospect of a more restrictive medical device clearance process for Class II devices is of significant concern for medical device manufacturers already struggling to navigate current FDA regulations, which have been regularly criticized for their lack of transparency and predictability. A paradigm shift in the clearance process may significantly increase time to market. As opposed to the current process, which attempts to balance safety and efficacy with fostering innovation, what is implicitly recommended by the report is a process where medical device manufacturers would incur additional costs conducting premarket studies and navigating a more complex regulatory framework.

    Of interest to all medical device manufacturers is the report’s focus on post-market performance, which will likely produce significant legislative and regulatory changes or, at a minimum, increased regulatory enforcement investigations and actions. In either event, the compliance costs will increase for medical device manufacturers that would have to undertake significant premarket and post-market monitoring studies, as well as engage counsel to handle regulatory enforcement investigations and actions.