The Medical Device Amendments of 1976 (MDA), to the Food, Drug, and Cosmetic Act (FDCA), divide medical devices into three classes according to user risk. Class I devices pose the least risk; Class III devices pose the most. Class I devices are subject to general controls such as labeling requirements. Class II devices are subject to general controls as well as special controls such as performance standards, post-market surveillance, and patient registries.

If a device cannot be determined to provide a reasonable assurance of safety and effectiveness under Class I or II controls, and it is either marketed as a life-supporting device or may cause an unreasonable risk of illness or injury, it is a Class III device. Consequently, Class III devices must undergo a rigorous pre-market approval (PMA) process outlined by the Food and Drug Administration (FDA). However, Class II devices typically obtain marketing clearance through a significantly less stringent 510(k) process. In fact, the 510(k) review process allows clearance without any independent clinical testing if the device manufacturer can demonstrate that its product is “substantially equivalent” to an approved product (also known as a predicate device) already on the market.

In June 2009, the Government Accountability Office (GOA) issued a report expressing concerns about the FDA’s approval processes for medical devices. In response to the GOA report, the FDA stated that it would conduct an internal investigation of the PMA process. The FDA also commissioned the Institute of Medicine (IOM), the research branch of the National Academy of Sciences, to perform an independent analysis to determine if the approval process appropriately protects patients and promotes public health.

In July 2011, the IOM concluded that reliance on substantial equivalence could not assure that devices reaching the market were safe and effective, and that the 510(k) process lacked the legal basis to be a reliable pre-market screen of moderate-risk Class II devices. Accordingly, the IOM recommended that the FDA go back to the drawing board and design a completely new device clearance process. The FDA disagreed and responded to concerns by accepting public comments and drafting guidance documents.

On September 29, 2014, two studies published in the Journal of the American Medical Association (JAMA) found that many medical devices are not sufficiently supported by evidence. A study by Diana Zuckerman evaluated the publicly available information for implantable devices cleared by the FDA through the 510(k) process between 2008 and 2012. The study found that companies are not providing sufficient summaries of their evidence to verify the devices’ safety and effectiveness despite being required to do so by the Safe Medical Devices Act (SMDA).

Specifically, the authors looked at 50 new devices and discovered that only eight of them had publicly available scientific data to support claims of substantial equivalence. The authors also identified 1105 associated predicate devices, and found only 31 of them had publicly available data to support substantial equivalence. Moreover, most of the evidence that was publicly available was non-clinical in nature, and some did not even provide an evaluation of the devices’ safety or efficacy.

Another study by Ian Reynolds determined that many studies completed after medical devices are approved by the FDA may not be useful. The researchers found that the FDA ordered 223 post-approval studies of 158 high-risk medical devices from 2005 through 2011. However, most of the studies were too small to adequately evaluate safety, and manufacturers were not being penalized for study delays. Furthermore, when studies actually uncovered problems, the FDA took little or no action – only one device was removed from the market.

Both studies’ results support the concerns articulated by the GAO and IOM previously. Moreover, they echo concerns repeatedly expressed in the past by Diana Zuckerman herself, who spoke about how little oversight the FDA exercised on medical devices in November 2011 at the Union of Concerned Scientists’ and George Washington University School of Public Health’s conference. She also published data about the flaws in the FDA review system in the Archives of Internal Medicine. Critics argue that the FDA cannot undergo true reform since the agency’s role of protecting public health is often superseded by the desire to get innovative products to market as fast as possible.

In response, the FDA reports that the publicly available evidence is merely limited because manufacturers are only required by the SMDA to provide either a safety summary or a safety statement for the public. The agency claimed that it actually reviews far more data than what is publicly available as part of the 510(k) process, and that the studies do not reflect the benefits patients have gained from safe and effective devices approved through the process.

New medical devices have functions and features that can become less connected or less similar to their predicate devices over time. Obviously, such new iterations may not be necessarily safe just because their predicates were deemed to be so. Thus, when such new devices are not sufficiently supported by publicly available evidence, it supports both closer scrutiny of manufacturers’ compliance with legal requirements and pushing the FDA to actually enforce the requirements. As Michael Drues warned in a recent article supporting the 510(k) process, “while a physician can kill patients one at a time, an FDA reviewer can kill patients thousands at a time.” Lawyers will find themselves inextricably involved in the development of stricter medical device regulations, and they will play a crucial role in balancing patient safety with industry progression.

On a positive note, the FDA has taken some steps to improve pre-market review and post-market surveillance. For example, the agency is undertaking a new post-market device surveillance plan that involves labeling every implantable device with a standardized, traceable code. The code will allow regulators and researchers to better track the implants’ performance and note any safety issues that arise.

Even with such ongoing FDA initiatives, the recent JAMA studies, as well as concerns about vulnerabilities in medical device software (exacerbated by doubts of cybersecurity preparedness and an inadequate reporting system for security incidents involving medical devices), mean that lawyers and regulators involved in the medical device industry are going to be busier than ever.


Neil Issar

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