The medical device industry in the United States is a massive market. Encompassing over 40% of the market of medical technology, the U.S. serves as the largest global consumer of medical devices. In 2022, the value of the U.S. medical device market alone was $184.61 billion.
Under the Food and Drug Administration (FDA), validation and quality assurance regulations of medical devices have fallen behind in guaranteeing the proper safety standards that American healthcare consumers should expect, especially in comparison to newer efforts by foreign agencies such as the European Commission. Concerns surrounding the lack of post-market consumer protections and the rise of improper off-label device usage plague the market for medical devices. The issue lies within the regulatory affairs of the FDA, by manufacturers who produce and solicit devices on the market, as well as the legislative body that sculpts the guidelines for the FDA to follow. Those who are primarily affected are the American consumers who put their trust in physicians to either endorse the efficacy of a device to perform to the best of its approved ability or to use devices off-label based on their qualified medical judgment.
The federal Food, Drug, and Cosmetic Act (FDCA) defines a device as “an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar... which is... intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease... intended to affect the structure or any function of the body.”
The purpose of such devices is to promote and protect the general health of consumers, while the main concerns for manufacturers are to ensure device effectiveness and prevent risk of harm. In response to the growing market for medical devices, the decline in assurance of patient safety has become a rising issue. The purpose of this article is to address concerns surrounding the regulatory oversight of quality and safety standards for medical devices in the United States, including the 510(k) premarket approval process and post-market off-label device usage, while also comparing the European model for medical device regulation.
In the United States, Congress has granted the FDA significant but defined authority to test, monitor, and classify medical devices, subject to statutory requirements and judicial review. Manufacturers submit devices to the FDA for approval when applying to enter the market. The market approval process by the FDA has been categorized into separate and distinct classes, depending on the relative device and its assessed risk. The purpose of the FDA, when regulating a device, is to guarantee its efficacy and safety. Ultimately, this means that a device must be safe for human use and will perform the way the manufacturer says it will. Data is collected by the FDA by either a manufacturer, outside third party, or both, and the device is either greenlit for market or sent back for further data collection.
In 1938, the United States Congress passed the FDCA, which granted the FDA its first form of federal regulation power to test and monitor the safety of drugs before being released to the public market. Under the FDCA, drug manufacturers are required to file an application with the FDA before releasing any new or untested drug into the public market. The application requires a full report and investigation proving the drug’s relative safety, however, the FDA is fully allowed to deny the application if it found the provided evidence to be lacking the appropriate safety standard.
Additionally, when the Medical Device Amendments (MDA) to the FDCA were passed in 1976, the FDA was given regulatory oversight to monitor medical devices. Under the MDA, the FDA created a three-tiered classification system that ranks and grades medical devices to determine the amount of control of regulation a device should receive before it may be released onto the market. This pre-market check is a source of quality control and validations placed upon manufacturers and medical device companies to guarantee a device is safe and effective for human use. The majority of new medical devices that apply for entrance onto the market must pass through what is called a 510(k) premarket notification process. The 510(k) process only applies if a premarket approval application is not required for a Class I, II, or III device, and if the device does not meet any exemptions.
A 510(k) is an application to the FDA that companies are required to submit showing that a to-be-marketed device is “substantially equivalent” to a device currently on the market, known as a “predicate device.”A predicate device is a legally marketed device that was legally marketed prior to May 1976 and does not require premarket approval, has been reclassified from Class III to Class II or I, or has been found to be substantially equivalent to another marketed device through the 510(k) process.
A 510(k) submission is also known as a Premarket Notification (PMN) to the FDA and requires that applicants sometimes submit clinical trial data alongside certifications for medical devices. The FDA has 90 days to respond to a 510(k) submission, either approving or denying the substantial equivalence to the predicate device. “The substantial equivalence standard... requires manufacturers to show that a proposed device has the same intended use and technological characteristics as a device already on the market.” This standard was established by Congress by the passage of the Safe Medical Device Act of 1990. In 1997, Congress passed the FDA Modernization Act, which established “good guidance principles” for the regulation of medical devices. Finally, in 2002, Congress passed the Medical Device User Fee and Modernization Act, which aimed to increase the rate at which medical devices are cleared for premarket approval. In short, substantial equivalence is a test used to show that a proposed new device is similar enough to an already legally marketed one.
Regarding the actual usage of a medical device, the FDA has limited authority in regulating the ability of physicians to prescribe devices for “off-label” use. Congress amended the FDCA, which prescribes the goal and purpose of the FDA, with the passage of the Food and Drug Administration Modernization Act of 1997. With this Act, Congress specifically laid out Section 214 which states:
“[n]othing in this Act shall be construed to limit or interfere with the authority of a health care practitioner to prescribe or administer any legally marketed device to a patient for any condition or disease within a legitimate health care practitioner-patient relationship. This section shall not limit any existing authority of the Secretary to establish and enforce restrictions on the sale or distribution, or in the labeling, of a device that are part of a determination of substantial equivalence, established as a condition of approval, or promulgated through regulations. Further, this section shall not change any existing prohibition on the promotion of unapproved uses of legally marketed devices.”
This act restricts the FDA’s interference on off-label device usage by physicians and medical providers. Nevertheless, the FDA has full authority to monitor and prohibit a device from entering interstate commerce when that device has been “misbranded.” Misbranding occurs when a device's labeling fails to meet FDA requirements, including but not limited to false or misleading statements, omission of required information, or improper promotion of unapproved uses.
Although the FDA regulates a device for market approval by manufacturers when entering interstate commerce, the FDA does not regulate the practice of medicine, and physicians are generally legally free to use devices for purposes other than their approved use. “From the FDA perspective, once the FDA approves a drug, healthcare providers generally may prescribe the drug for an unapproved use when they judge that it is medically appropriate for their patient.”
Under the FDA, medical devices are separated into a three-class system. Class I devices are generally the lowest-risk of the three and are subject solely to general controls. They typically do not require 510(k) clearance to enter the market. An example of a Class I device may include “elastic bandages [or] tongue depressors.” Class II devices are usually regarded as moderate risk, “such as pregnancy test kits and powered wheelchairs,” and require special controls when general controls are inappropriate. Most devices under Class II must receive 510(k) clearance to enter the market. In some situations, a Class II device may be exempt from 510(k) and reclassified as Class I if the FDA makes a finding that a report is “not necessary to assure the safety and effectiveness of the device.” The new finding for the device is then published to the Federal Register. Finally, because Class III devices are higher-risk devices than Class I and II, they generally must receive premarket approval instead of 510(k) clearance. Class III devices are subject to general controls and are the default category for all medical devices but may later be reassessed and recategorized as either Class I or II.
Until the 1990s, most of Europe relied on the judgment of their independent nations for the regulation of medical devices. It wasn’t until the adoption of the New Approach Directives in May of 1985 by the European Council (EC) that Europe created a uniform body for the creation and oversight of regulation across the European Union (EU). The EC set a guideline of “Essential Requirements” to guarantee the safety and performance of all medical devices. A device must receive a European Conformity (CE) mark by the EC to be approved among all the members of the EU. A CE mark standard certifies that a device is safe and meets the requirements set forth by the EC. Similar to the FDA three-tiered classification system, the EC has four separate categories that determine the invasive nature and of risk of harm to be associated with the respective device and requires a higher evidentiary showing of safety and effectiveness per category.
Low-risk devices are categorized as Class I, and manufacturers are only required to self-declare conformity to the standards supplied by the Essential Requirements. This is often done through the respective agency in that host nation, such as the “Medicines and Healthcare Products Regulatory Agency (MHRA) in Great Britain.” Moderate and high-risk devices require both clinical and non-clinical data when evaluating a device. Class Type IIa and IIb are considered moderate risk and may be compared to a similar device already on the market. When a manufacturer claims that their device is similar to another device currently on the market, a comparative literature review is typically included. Class III devices are noted as high risk and generally require clinical studies as evidence in order to receive CE marking, Additionally, Class III devices, posing the highest risk to patients, generally includes the majority of essential medical instruments (such as pacemakers, heart valves, cerebral simulators, etc.), and therefore; these devices must undergo further performance and safety checks far outweighing the requirements of lower-classed devices and must also submit documentation to the Notified Body for approval.
Manufacturers of medical devices then select and hire one of around 80 different “Notified Bodies” to evaluate their device. These for-profit companies determine whether the clinical and/or comparative review meets the standard of the category of the device, and if so, the device is then given a CE mark to certify that the device has met the Essential Requirements for safety and performance, but not necessarily effectiveness.
Once a device is on the market, “manufacturers are required to report all serious adverse events to the Competent Authorities.” All information regarding medical devices and their safety standards is computed onto a uniform database called the European Databank on Medical Devices (EUDAMED). In addition, “[EUDAMED] contains data on manufacturers; certificates issued, modified, suspended, withdrawn, or refused; and clinical investigations.” It has been a mandatory requirement since 2011. Post-market surveillance may also be required if a device is medium to high risk, and the long-term safety is relatively unknown to the device or other means. Member states of the EU are not allowed to introduce more stringent regulations regarding medical devices and are required to repeal all contradictory legislation that may remain prior to the EC creation.
Regulations regarding medical devices in the EU were harmonized in the 1990s with the passage of three directives, most notably Council Directive 93/42/EEC of 14 June 1993. This Medical Device Directive (MDD) set the standard of classification for risk by which manufacturers of devices were allowed to choose for their products conformity assessment procedure. Overall, the directive “left the exiting framework untouched” and was instead “a technical revision,” yet the MDD brought software into the definition of medical devices as well as laid out the standards for risk classes and advanced quality system conformity among manufacturers.
The MDD was the standard protocol for the EU until its newest iteration/replacement, Regulation (EU) 2017/745 (MDR) in April of 2017. The MDR effectively replaced the MDD as well as the Active Implantable Medical Device Directive (AIMDD) and covers both medical devices and active implantable medical devices. These changes brought by the MDR were to be fully implemented by manufacturers by May 2021. Some additions brought by the MDR include more stringent processes for the designation and oversight of notified bodies, inclusion of nonmedical devices with similar risk characteristics as analogous medical devices, a new risk classification system for in vitro medical devices, expansion of EUDAMED, reinforcement for clinical evidence rules, and improved market surveillance mechanisms.
Under Article 2 of the EU MDR, a “Medical Device” is defined as:
“Any instrument, apparatus, appliance, software, implant, Regent, material, or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes: diagnosis, prevention, monitoring, prediction, prognosis, treatment, or alleviation of disease. Diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability. Investigation, replacement, or modification of the anatomy or of a physiological or pathological process or state. Providing information by means of in vitro examination of specimens derived from the human body, including organ, blood, and tissue donations; And which does not achieve its principal intended action by pharmacological, immunological, or metabolic means, in or on the human body, but which may be assisted in its function by such means.”
The main purpose of adopting the MDR was to ensure “greater protection of public health and patient safety.” Largely, the classification principles under the MDR have remained essentially the same as the MDD by way of being a rule-based system. However, the classification schemes have become even more detailed. The MDR uses the rule-based system to consider the intended purpose of a medical device, such as invasiveness, contact type, anatomical location, energy source, and length of contact. The system relies on the four classes: I, IIa, IIb, and III, yet class I can be subdivided into sterile (Is), measuring (Im), and reusable (Ir). These classifications are determined by a device’s intended use and risk of harm, while some devices, such as custom-made, are unclassified and marked as special devices. Manufacturers of devices are required to navigate all the rules of the MDR to determine the necessary classification of their device.
In the United States, one crucial aspect for medical device approval by the FDA is the 510(k) substantial equivalence process. Under the EC, manufacturers may follow a similar process to enter the market, yet this process requires a “demonstration of equivalence” and is a lot more tedious than a simple comparison to a predicate device. Under the MDR, manufacturers are required to complete many different submissions and risk-based certifications to receive a CE mark for market approval.
One step in the process is the clinical data requirement. Unlike a 510(k) submission in the United States, which allows a manufacturer to show substantial equivalence between a device for submission and a currently marketed device in order to directly enter the market, the EU MDR only allows for comparisons between device submissions and current CE marked devices and does not automatically lead to market approval. Under the EU MDR, manufacturers have the option to demonstrate equivalence between their device and a CE marked device in order to satisfy only the clinical data requirement—one of many requirements by the MDR. To do so, manufacturers must show a “demonstration of equivalence” between the two devices, yet this is a challenge in and of itself. The MDR requires a higher level of similarity between the two devices than the 510(k) process in order to compare the risk of the devices and mediate any potential concerns of safety and lack of effectiveness that could result. For a device to claim equivalency under the MDR, it must match in “technical, biological, and clinical characteristics.” For example, if a CE-marked device has the same technical and clinical characteristics but uses a different material than the submission, it cannot claim equivalency. “Two of the three is not good enough.”
The role of MDR is relatively new, and manufacturers are still navigating how it operates and whether it will perform according to the hopes of the EC. Nevertheless, the system operates by creating a risk-based classification system very different than that used by FDA. Even the similar 510(k) process has been stripped in scale by the MDR to combat lack of quality data and testing of devices. The FDA must consider decreasing reliance on the substantial equivalence test and should instead consider implementing a more structured risk-based market approval process. While the 510(k) process does exist to allow for innovation and scientific improvements for medical devices, the MDR has created a newer process by which clinical data and testing is at the focus for market approval, and the FDA should consider these modifications in their own regulatory scheme.
Another place where the FDA can and should reform its regulation is in off-label device use by physicians. Under the FDCA guidelines, the FDA is given large discretion when regulating medical devices. However, generally, the off-label use of medical devices has received little scrutiny towards the judgment of healthcare providers, including physicians who prescribe and administer the device. The off-label use of a medical device can be described as the usage of the prescribed device in any way other than the approved use by the FDA. Generally, physicians and medical providers hold full discretion on how to use a medical device, even if that use has not been approved by the FDA. The FDA does not prevent medical providers from off-label use of devices. For example:
“In one such circumstance, a surgeon’s implantation of orthopedic screw devices during the patients’ spinal surgeries was, as a matter of law, a legally permissible ‘off-label’ use which did not violate the FDA regulations, even though the FDA had not granted approval to market the screw device as a pedicle screw device and the device was classified for investigational use only, where the device had been approved for use in long and flat bones, and the FDA documents indicated that the use of the screws in spinal surgeries was, in fact, a permissible ‘off-label” use.’”
The off-label use of medical devices has created an issue for regulating and guaranteeing the quality of devices by patients who trust in the FDA’s assurance that a device will be used for the purpose that it is approved for. That said, many scholars and physicians encourage and support the off-label use of drugs and medical devices. Currently, off-label use is a common practice among physicians and can sometimes be the difference between minimal and optimal care.
The issue is not when the off-label use is a success—the issue is when off-label use causes irreversible or untraceable harm to a patient. As noted earlier, once the FDA comes to the determination that a Class I, II, or III medical device may be marketed, a physician who chooses to use that device is given full discretion on how to prescribe it and “is not restricted to the uses indicated [by] FDA regulat[ions].” While physicians may typically prescribe devices however and whenever they please, they must rely on the information provided by the FDA on how a device is marketed by the manufacturer for its initial intended use. The discussion of how and why physicians should use medical devices is a complex issue. However, the FDA itself does not regulate nor condemn the off-label use of medical devices. The dichotomy comes between the FDA’s regulation and suggested use for medical devices and the physician’s ability to ignore those suggestions. Specifically, the FDA released a statement in 1982 that said the FDCA does not “limit the manner in which a physician may use an approved drug. Once a product has been approved for marketing, a physician may prescribe it for uses or in treatment regimens or patient populations that are not included in [the] approved labeling.”
Pharmaceutical companies and medical device manufacturers cannot list their products on the market until they provide evidence to the FDA that a device is safe and effective for its intended use. While manufacturers must prove with clinical data that a device does what it is claimed and branded to do, physicians may opt to use a device for any additional purpose if doing so is for what they believe to be in the best interest of their patient. To that end, physicians are given unfaltering discretion to use a device and medication beyond its approved FDA purpose.
Many critics within and outside the medical field question why physicians are afforded such an unlimited ability. Medical device companies spend significant amounts of time and money when developing a medical device. Although the process of developing a drug or device is not without flaws by oversight, it should be acknowledged that a lot of research goes into guaranteeing a safe and effective use of a device, which nevertheless, may be undervalued by a physician when it comes to implementing that device into a patient’s care or by way of a device sales rep trying to promote and encourage the sale of a specific device. Physicians must ask themselves to consider the best treatment option and procedure for using a medical device, especially if that use is off-label. In general, physicians may sometimes be motivated by the ability to use the advancing technology that comes with a new device. This can potentially reap higher profits for physicians and the manufacturers whose devices are used. The American Medical Association has supported the off-label use of medical devices regarding the “autonomous clinical decision-making of a physician.”
Although it is a staple in medicine that a physician has the autonomy to make the best educated care decisions for their patient, off-label use of devices has become an increasingly alarming issue for patients who worry about the risk of harm and the possibility for malpractice. Much of this concern revolves around the high incentives that physicians receive from manufacturers, both in research and financial gain, to use their products. Supporters of the off-label use of devices mention the legal liability that physicians and manufacturers both face when suggesting that any off-label use by a physician is appropriate because of the high burden on physicians as well as high risk of performance. Yet only a relatively small number of patients who have sought damages through tort liability have been compensated, and this only occurs after the harm has been done. While there are benefits from off-label use through advancements in technology, what is important to consider is what must be done to ensure safety and minimize the risk for patients.
Given Congress’s firm stance on the FDA’s authority to regulate off-label use of devices and the medical community’s public views in support of off-label use of devices for therapeutic advancements in technology, the concern then falls back to when the FDA may act and what may be done. Many who criticize the lack of authority for the off-label use of devices suggest firmer action be taken to “subject off-label uses [of medical devices] to the preapproval process.” In addition, some policy analysts suggest higher post-market scrutiny of FDA-approved products. The issue with post-market scrutiny does not solely lie with off-label device use but also with monitoring. The FDA relies highly on physicians and device manufacturers to report any problems with a device post-market approval; nevertheless, this leads to only a small percentage of issues with post-approval devices being addressed or reassessed by the FDA. While the ability of the FDA to monitor and regulate post-approval devices and the off-label use of such approved devices has been severely limited in the past, as well as underreported by today’s standards, the FDA has much discretion in determining what a device’s intended use is for and whether the evidence in safety and efficiency medical device companies submit matches the claims they assert.
Overall, it may appear that the differences between the firmly established FDA regulations and the EU MDR seem minute, especially given the relative newness of the MDR, yet the key aspects of the two systems hinge upon the 510(k) market pathway and the MDR rule-based classifications. Specifically, the FDA relies heavily on predicate device matching of devices for manufacturers to enter their devices on the market, yet the MDR requires manufacturers to follow a systemic set of rules for all devices. While it is true that the MDR does allow for a comparison-based evaluation for similar devices, the process of what is known as “equivalent devices” is limited to a clinical evaluation only and does not account for the entire conformity assessment. Instead, the MDR allows for the potential use of clinical data of comparative devices. Nevertheless, the MDR is much stricter in determining equivalences than the FDA. For a device to be deemed “equivalent” to another, the use of identical materials or indications and body regions are required and limited to equivalence between CE marked devices only.
Additionally, the EU MDR has a broader scope of risk-based classifications than the FDA when categorizing medical devices. As discussed, the FDA ranks devices in Class I, II, or III, depending upon the potential risk of harm. The EU MDR, on the other hand, first separates devices into four distinct categories: non-invasive, invasive, active medical, and special. From this categorization, devices are separated into risk classifications. This risk-based classification determines the amount of data and clinical testing a medical device may be required to produce before being submitted to the market. In addition, the classifications consider any and all clinical studies or adverse effects of a device. The requirement of most devices to submit clinical data differs from the FDA, in which Class I and II devices are not required to submit to risk-based clinical testing.
Post-market scrutiny, though with benefits and issues, has often been a policy consideration for the FDA, as well as for critics of the FDA’s stance and usage on premarket approval. Nevertheless, post-market regulation, while ineffective in determining whether a device should enter the market, is instead very effective in curbing the improper off-label usage of medical devices. Many policy analysts suggest a closer scrutiny of post-marketing FDA-approved products. A more stringent regulation consisting of “improved monitoring of marketed drugs and devices [c]ould give health professionals and FDA officials better information about the safety and effectiveness of both on and off-label uses.”
The FDA post-market system relies on the reporting by medical practitioners and manufacturers for adverse events. Yet, a problem arises when those responsible for reporting issues from off-label use are the same ones responsible for the off-label use. A suggestion of post-market surveillance could come from monitoring medical records and databases, such as through Medicaid/Medicare, or by creating registries for medical devices to document off-label usage of devices and their effects on patients. Legislative incentives are another method to produce post-market surveillance of off-label usage. Certain suggestions even consider offering extended market exclusivity for collecting clinical data on off-label usage.
Much of the FDA’s decision-making framework is subject to discretionary findings rather than legal judgments. The following parts of this article will highlight the standard of review courts use when FDA classifications are challenged in litigation and the use of litigation by patients and consumers for harm done to their person.
Interested parties and device manufacturers alike may challenge an FDA classification in court, and courts must set aside FDA decisions that have been found to be “arbitrary, capricious, [and] an abuse of discretion.” The standard that follows from the Ninth Circuit states that an arbitrary and capricious decision made by an administration is one that relies on:
“…factors which Congress has not intended it to consider, entirely failed to consider an important aspect of the problem, offered an explanation for its decision that runs counter to the evidence before the agency, or is so implausible that it could not be ascribed to a difference in view or product of agency expertise.”
Nevertheless, courts tended to refrain from supplementing their judgment with that of administrative agencies and relied on the Chevron standard when determining the discretion of the FDA to classify or reclassify a medical device.
For example, in the case of Contact Lens Manufacturer’s Ass’n v. FDA, a commercial association sued the FDA over its decision to refrain from reclassification of contact lenses and instead classify them according to the product’s alleged safety and effectiveness. Manufacturers of the lenses lobbied to have their devices reclassified from the initial Class III determination to a Class I device, which the FDA proposed to stop. Initially, the Contact Lens Manufacturers Association (CLMA) petitioned the FDA to reclassify the lenses as Class II, yet the FDA found Class I to be more permissible. The FDA held a period of public comment as well as received expert opinion led by clinical studies to make their initial determination. However, a year after making their initial decision to reclassify the lenses, the FDA repudiated and decided to leave the lenses as Class III. When evaluating the public comment, the FDA determined that the data collected from the clinical studies was not sufficient to hold a finding of valid scientific evidence and, even such, they would still “fail to establish the safety and effectiveness of [the] lenses as a generic type of device.” The CLMA argued that the FDA had “disregarded a medical consensus favoring reclassification and ha[d] rendered insensible the requirement of ‘valid scientific evidence.’” Overall, the United States Court of Appeals for the District of Columbia Circuit held that the FDA was “at least arguably consistent with the statutory scheme” and “that [the] FDA’s concerns over the adequacy of rigid gas permeable lenses as a generic class were sufficient to uphold its decision.” It should be noted, by the Supreme Court’s decision Loper Bright, that Chevron deference is no longer the current model when interpreting the force of law by which the FDA has authority. By this decision, the Court has presumptively returned to the standard set in Skidmore, which relies on the persuasiveness of an agency on a case-by-case test to determine the amount of deference given to their interpretive rules.
The purpose of the FDA medical device assessments is to provide a “reasonable assurance of the safety and effectiveness” of devices permitted to enter the market. A safe device is one in which the probable benefit of health outweighs its probable risk, and an effective device is one that “produces clinically significant results in a significant portion of [its] target population.” Those who criticize the FDA believe that regulation of devices should not come from pre-market approval but instead from post-market surveillance. The focus on post-market surveillance is to target the efficiency of devices in actual patients, yet opponents to this argument believe some premarket review is essential to prevent manufacturers from selling sham or risky products. Nevertheless, discussions about time and productivity counter head-to-head with the safety and efficiency of devices.
The policy rationale behind improving oversight of medical devices aims to protect the safety of the consumer and ensure the efficacy of a device; nevertheless, large medical device manufacturers often complain about the FDA pre-market requirements as well as the inability to advertise a device for off-label usage. And, in circumstances where manufacturers fail to recommend a device for an FDA-approved purpose, liability may follow. An example of such is the case of United States v. Prometheus Group, et al., where the United States relied on the False Claims Act (FCA) to prosecute medical device manufacturers. In this case, the United States alleged that Prometheus Group, a medical device manufacturer, trained healthcare providers to reuse disposable rectal probes, which went against the guidance and recommendation of the FDA. As a result, healthcare providers submitted false claims for payment to Medicaid for services involving the misuse of the probes.
In the complaint, the United States alleged that Prometheus put the health and safety of vulnerable Medicaid patients at risk to gain a marketing advantage and reduce overhead costs. The device in question was “a pelvic muscle rehabilitation system and accompanying rectal pressure probe used to treat pelvic floor disorders.” As far as the FDA is concerned, the device had been approved for single-person use only with the intent of being discarded afterward. But the United States alleged that Prometheus had instead “trained providers to reuse the device on multiple patients by covering the probe with a glove or condom” as well as “instruct[ing] providers to re-use another company’s probe with a different pelvic rehabilitation system it manufactures,” despite the packaging displaying warnings claiming “single-use only” and “discard after use.” The precedent of this suit offers a warning to manufacturers of the potential of liability when disregarding the FDA and sets a standard regarding the intent prosecute.
Currently, federal law “prohibits the introduction of a drug or device into interstate commerce without approved labeling for intended uses (an act known as ‘misbranding’),” and the federal government has pursued enforcement actions for promoting drugs and devices for [these] off-label uses.” In addition, “[w]hether a company will be deemed to have misbranded a product by promoting it for off-label use in violation of the FDCA may depend on whether the use is inconsistent with the FDA-approved labeling and whether it qualifies as an ‘intended use’ by the company, as set forth by the ‘intended use’ regulations.”
In determining the “intended use” by a company, the FDA has stated that when determining relevant evidence they will rely on a “case-by-case basis... [to] determine what evidence is relevant to whether a company is engaging in off-label promotion... from the viewpoint of whether a reasonable fact finder would determine that the manufacturer or seller intended the product to be used for off-label purposes.” Specifically, the FDA has said “limiting evidence of intended use to only promotional claims would allow manufacturers to circumvent FDA regulation by masking their true intent, either by simply omitting explicit promotional claims or by making claims that are not true.”
American consumers are at a higher risk of harm from medical devices than their European neighbors. As discussed previously, the FDA takes a risk-of-harm approach when regulating medical devices and considering their potential approval for the market. Additionally, many devices enter the market through 510(k) predicate device comparisons, where devices are assessed based on similarity to previously approved devices.
Across the pond, manufacturers must follow sets of rule-based classifications that align with a device’s intended use. In the EU, if a device’s intended use is to develop over time from off-label usage, the device will be required to be reclassified. The intended purpose of a device, as set by a manufacturer, determines a device’s classification, not the class of other similarly situated devices. For example, “two sutures that have the same composition may well have different intended purposes” and have different classifications requiring more or less rules and sub-rules for manufacturers to follow. The rule-based classification and device reassessments under the EU MDR preemptively protect consumers. In addition, manufacturers are required to demonstrate compliance with each rule that a device is assessed under to place their device on the EU market.
The EU MDR has raised the based the bar for how consumers, as well as manufacturers, view risks of safety and compliance. By frontloading compliance and requiring vast clinical data, the EU MDR is effectively placing the burden for quality assurance of products and decreasing the risk of harm to patients on the manufacturers themselves. The FDA and device manufacturers within the United States rely heavily on self-reporting in post-market surveillance to guarantee the efficacy of and safety of devices, yet the problems that we’ve discussed could be prevented by a rule-based standard in which surveillance is front-loaded rather than addressed after the fact.
As stated, the American consumer must be the whistleblower when reporting harm or injury from a medical device. This issue of relying on physicians and manufacturers to report concerns to the FDA is waiting for harm to occur. When an issue is spotted by a manufacturer or a physician, the problem is often raised by a consumer or a group in a class action.
Additionally, many patients who suffer similar harm from a medical device may elect to bring claims by multidistrict litigation. Multidistrict litigation is a method in bringing claims by larger numbers of plaintiffs to courts for generally complex legal issues, such as defective medical devices, where many pre-trial matters are consolidated before one federal judge and legal issues are streamlined. Medical device manufacturers independently collect post-market surveillance oftentimes for determining quality assurance and validations of devices, yet these surveillances rely heavily on complaint data from patients themselves. This is the issue that American consumers must face. Data is not collected until a problem has been found, and the problems are found mainly by consumers.
A second issue of relying on independent post-market surveillance is the lack of complaints. Manufacturers, when determining if a device is within compliance, rely on the complaints of groups or individuals to determine whether to internally audit a device and its manufacturing process. While it may appear conspicuous to evaluate the quality of a device when an issue has been raised, there are a multitude of factors that undermine the ability and/or credibility of patients who receive or have been impacted by a medical device.
Consumers cannot easily complain about potential harm, especially when complaining about a medical device. First, whenever a procedure has been performed, there is a certain level of anticipated discomfort that is to be expected, and it is hard to discern between the actual procedure/treatment and the used medical device. Second, patients who are recipients of medical devices are left to question whether any discomfort they may experience is routine and predictable from the procedure, whether the pain may be slight and acute if the magnitude is much larger, or if the pain is directly related and traceable to a medical device. Third, considering the later question of the traceability to medical devices, additional questions must be addressed, such as if the device used was temporary or permanent, if it was for single usage, if the device was implanted internally, or if the device was used off-label by a physician. Devices used more frequently with little to no knowledge by the patient of their use may be extremely difficult to identify when locating potential sources of pain. Traceability is the biggest problem for consumers when determining the placement of harm and the potential risk of a medical device.
“When medical devices are determined to be unsafe, it is front page news. Consider the plight of surgical mesh used to repair hernias that had severe side effects, the cement application device used in spinal fusions that grew bone where it was not supposed to, or metal-on-metal replacement hips that caused flesh rotting metallosis. These devices were recalled, class action lawsuits were filed, and policymakers rightly focused on how these harms could have been avoided. But the same is not true of ineffective medical devices—those that might not be killing people or causing horrendous side effects, but that can nonetheless cause considerable harm when they do not do what they are supposed to do.”
Whether harm and injury may be easily located or mistaken for post-procedural aches and pains, the American consumer is burdened, not only to determine the exact causation of their harm, but also to decide if they can prove it. Sadly, many consumers who experience difficulty and injury from medical devices, with or without knowledge of how and why it occurred, just learn to live with it.
It is the responsibility of manufacturers, as well as the FDA, to recognize and find device concerns and potential failures before they arise to mass levels of harm. Metal-on-metal hip replacements are an example of a medical device that caused serious harm in recent years. In the case of In re DePuy Orthopaedics, Inc. Pinnacle Hip Implant Prod. Liab. Litig., a federal jury in Dallas awarded six plaintiffs a total of $247.49 million in damages due to pain and suffering caused by deteriorating metal on metal hip implants by DePuy Orthopaedics Inc. Plaintiffs showed that the hip implants had prematurely failed by shedding metal internally that caused inflammation and damage to soft tissue and bone tissue ultimately requiring surgical replacement. Jury members found DePuy as well as Johnson & Johnson liable for “design defect, negligent design, inadequate warning, manufacturing defect, negligent manufacture, negligent misrepresentation, fraudulent concealment to both plaintiffs and surgeons and deceptive business practices.” Since this case, thousands of other suits have been filed with DePuy already paying out over $1 billion in settlements. The device by DePuy initially entered the market through the FDA 510(k) approval process short-cut, yet metal-on-metal hip replacements have since been reclassified to require premarket approval. Metal-on-metal implants, as well as many orthopedic devices, are categorized as Class III by the FDA but have been able to receive 510(k) market clearance in recent years. As a result, many of these high-risk devices have reached patients without prior clinical testing but with a high cost of failure to the patient.
The Institute of Medicine has extensively documented significant concerns regarding the 510(k) process, specifically its inadequate safeguards in allowing moderate-risk devices with minimal clinical studies and data testing to enter the market. Because of this, the need for post-market surveillance and pre-market clinical data testing, especially for moderate-risk devices, has risen in recent years and raised many concerns for public health and public interest. Oftentimes, the public interest is piqued by high-profile recalls, for example, “vaginal mesh products, [that resulted in] nearly two million injuries and more than 80,000 deaths linked to faulty medical devices.” The 510(k) pathway to market approval allows for devices to be used and approved with very little to no clinical data submitted to the FDA.
While at first glance, the 510(k) approval process for predicate devices seems reasonable, problems have arisen from decades of devices that claim “substantial equivalence” with one another but, in actuality, diverge drastically from their initial predicate device. For example, “certain metal-on-metal hip implants were cleared without clinical studies and based on predicate medical devices that did not demonstrate safety and effectiveness or were discontinued.” Devices cleared today through 510(k) may be compared to devices initially cleared 40 or 50 years ago with little to no clinical validation recorded. In addition, devices seeking 510(k) clearance need not show evidence of effectiveness. Even Class III devices, which require submission to a pre-market review process, can game the system with effectiveness showing through “clinically significant results.” However, “clinically significant results” are not defined in the FDCA and can easily be satisfied by “a single clinical study that might not even be a randomized trial” or studies with no statistical data.
The 510(k) process requires some much-needed redevelopment as it allows for too much inconsistency between predicate devices and their modern counterparts. In short, there is a legislative need for FDA clarification under the FDCA on the functions guaranteeing efficacy when regulating medical devices. Additionally, the FDA itself must consider adopting the newer EU MDR model when assessing device risk. Only time will tell how effective this new European model will be. Still, what is needed as of now stateside is the decrease in 510(k) predicate device market entry and a firmer requirement to produce effective clinical studies before harm has occurred. While there may be an advantage to a quick and easy entry into the American medical device market, the risk of harm should be the strongest incentive for placing the needs of the consumer first.
The FDA must undergo comprehensive reform to its 510(k) approval process for pre-market evaluation and substantially strengthen its oversight of off-label use in post-market surveillance. The EU’s processes offer guidance as to what those reforms should be. The concern surrounding off-label usage of medical devices, as well as pre- and post-market approval, are issues that impact many American healthcare consumers. The ability of a consumer to know what medical device has been approved, clinically tested, and supported by statistical data and will be used for its FDA-approved purpose may seem arbitrary, and many Americans are left unaware of the risks they take when being prescribed a medical device. Arguments by critics of increased regulation, as well as those who support off-label usage of drugs and devices, often center around suffocating innovation and scientific discovery and the risks of limiting the autonomy of medical professionals. Yet, the issue that should instead arise is consideration for consumers. At the core of medical device reform and complaints about FDA oversight of devices is the focus on those impacted directly—the consumer. The purpose of regulation is to mitigate risk. When regulation is limited, and in some circumstances completely uprooted, the result is an upsurge in the risk to public health and safety concerns for the consumers of medical devices.
A finding in 2021 indicated that more than 80,000 deaths and 1.7 million injuries had been linked to medical devices within the previous decade. Currently, about 10 percent, or approximately 32 million Americans, have an implanted medical device within them. Today, the United States makes up around 40 percent of the worldwide industry for medical devices in revenue and sales and is the largest medical device market globally. Despite the huge effect medical devices have on the American medical industry as well as the global market, regulations surrounding devices have primarily focused solely on ensuring devices are not “adulterated or misbranded.”
There is a lack of adequate regulation focused on the consumer. Sadly, when reforms are made or proposed, they are the result of mass harm and public uproar. The needs of the consumer must be at the forefront of the FDA medical device validation and approval process. Less leniency and toleration must be given for manufacturers hoping to enter the American market. Device review and safety validation must be conducted comprehensively prior to market approval to prevent potential harm to patients, and patients should not have to discover that a medical device was used off-label only after a medical catastrophe.
Medical device regulation is a requirement of the FDA by Congress, yet patient safety is also a responsibility of the physicians that use and administer medical devices. Just as device manufacturers have a legal obligation and duty to provide quality devices, physicians have the same duty and ethical obligation to administer the best treatment of care to their patients. Deciding when and how and which device to use falls under that legal duty. As discussed earlier, physicians hold much unilateral and almost total judgment in using an FDA-approved medical device. Therefore, physician discretion should be used in full faith and confidence that the device will be most efficient to the patient while mitigating present and future harm. When that discretion has been abused, physicians are and should be fully liable under the law.
As of now, the FDA has been supplied much power by Congress when regulating medical devices, and that power should focus more on risk of harm when considering improvements to be made in regulation. A guiding example of medical reform comes from the European Union MDR, a relatively new system with many similarities and differences from the FDA. Whether or not this system will be a success for Europe is still left to question, yet this new change aims the spotlight to the United States and the FDA in making new reforms as well.
