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FDA Consent

FDA Medical Device Regulation and Informed Consent


John J. Smith, Mary E. Jensen, and Jacques E. Dion


New medical devices are subject to a regulatory

scheme designed to ensure safety and effectiveness

that is administered by the United States Food and

Drug Administration (FDA). Gaining approval to

market a device for a specific clinical indication may

be time-consuming and costly, particularly for one

that poses a potentially unreasonable risk of patient

injury and represents genuinely new medical technology.

The difficulty of gaining FDA approval has led to

the use of devices for indications other than those

approved by the FDA and to the clinical use of products

that lack any formal FDA appr1oval. Such non-

FDA approved uses raise the question of what patients

subjected to these products should be told as

part of the informed consent process.

FDA Medical Device Regulation

Current FDA regulation of medical devices is

based on the Food, Drug, and Cosmetic Act (FDCA)

as modified by the Medical Device Amendments of

1976 (MDA). The MDA substantially changed U.S.

device regulation, integrating many features that had

previously existed only in drug regulation. New devices

are generally subject to a premarket notification

system under section 510(k), requiring a manufacturer

or other sponsor to notify the agency of its

intention to market the product. After this notification,

the FDA must affirmatively grant permission for

marketing to proceed. Certain devices that pose a

potentially unreasonable risk of patient injury are also

subject to a premarket approval process, another established

drug regulation device that typically involves

clinical trials. The overall goal of this regulatory

scheme is to ensure that a marketed medical

device is safe and effective for the indications described

on its FDA-approved product label.

Enforcement of the FDCA is primarily the responsibility

of the FDA. The agency directs its enforcement

actions against parties who market products

that either lack any FDA approval or that are marketed

for an indication other than that approved by

the agency (so-called off-label use). Importantly, it is

a long-standing regulatory doctrine that a licensed

physician may use a legally marketed device for any

indication that he or she believes is appropriate, regardless

of whether that use is agency approved (1).

This “practice of medicine” doctrine recognizes that

the FDA regulates devices, not medical practice (2).

The agency can, however, regard the acquisition of a

device for a nonapproved indication as a marketing

activity and act against the physician who does so.

This concern notwithstanding, enforcement actions

stemming from the use of nonapproved devices are

primarily directed at manufacturers and other individuals

who actively market such products, not the

physicians who use them.

The heart of the device regulatory scheme is a

three-tiered classification system under which pre-

1976 products are classified by the risk they pose to

patients, with an increasing regulatory burden as the

device ascends in class.

Class I Devices.—These are products that do not

pose a potentially unreasonable risk of patient illness

or injury. Such products are regulated only via general

controls, such as general labeling requirements

and good manufacturing practices. These controls

apply to all class I devices as well as to devices of

classes II and III. The FDA does not assess these

products individually nor is there a requirement that

safety and effectiveness of the individual product be

established prior to marketing. Examples of products

in this category include tongue depressors and


Class II Devices.—These present a greater risk of

harm than do class I devices and are subject to additional

regulation in the form of special controls, which

may be established by the FDA. Although regulation

may be more stringent than with class I devices, there

is no individual FDA evaluation of these products.

Generally, this class includes higher-technology products

that do not by themselves maintain life, such as

cardiac monitors, tampons, and oxygen masks.

Class III Devices.—These are “represented to be

for use in supporting or sustaining human life or for a

use which is of substantial importance in preventing

impairment of human health,” or that “present a

potentially unreasonable risk of illness or injury” (3).

Technically, all products in this class are subject to a

premarket approval process, which requires that a

manufacturer establish the safety and efficacy of the

device prior to its marketing. Pre-1976 class III devices,

however, are “grandfathered” and may continue

to be legally marketed until the FDA requests

safety and efficacy data and the manufacturer fails to

provide it, or the supplied data fail to demonstrate

safety and efficacy. Products substantially equivalent

to pre-1976 class III devices also enjoy this regulatory

reprieve. Class III includes implantable devices, such

Address reprint requests to John J. Smith, Department of Radiology, Massachusetts General Hospital, 55 Fruit St, Boston, MA 02114.

© American Society of Neuroradiology



as stents and heart valves, as well as products used

within the body, such as angioplasty catheters and

coils for embolization.

Devices developed after 1976 are split into two

groups, those that are substantially equivalent to pre-

1976 devices and those that are genuinely new products.

A party seeking to market a new device must

generally notify the FDA of its intention to do so

under the MDA’s premarket notification system, often

referred to as 510(k), the statutory section outlining

the requirement. Should the FDA determine that

a device is substantially equivalent to a pre-1976 device

or represents an evolutionary change of such a

device, that device is classed with its pre-1976 equivalent

and may be marketed subject to the same regulatory

standards applied to the existing product.

Thus, substantially equivalent devices do not escape

regulation, but they are only subject to the regulation

faced by their pre-1976 predecessor.

Genuinely new devices developed after 1976, which

by definition have no pre-1976 equivalent, are automatically

considered class III devices. Technically, the

FDCA does allow reclassification to class I or class II

in certain instances, although this does not apply to

any device whose potential risk to patients would

place it in class III (3). Practically speaking, this reclassification

provision is rarely, if ever, used with

potentially high-risk products. Accordingly, any such

genuinely new device is subject to a formal premarket

approval process. This process requires reasonable

assurance that the device is safe and effective for its

intended use. Safety and efficacy are generally established

via clinical trials that focus on specific clinical


The device regulatory scheme has important implications,

particularly for genuinely new medical products

developed after 1976 that carry a degree of patient

risk, which places them in class III. These

devices are automatically subject to the premarket

approval process prior to any legal marketing. The

clinical trials that underlie this process are often involved,

time-consuming, and costly, and typically yield

approval for only a single clinical application. The

cost alone may be sufficient to prevent a manufacturer

or other sponsor from pursuing marketing of

the product. The time involved in conducting clinical

trials also makes it difficult for FDA approval to

reflect the latest medical developments. Furthermore,

the practice of medicine doctrine, which allows physicians

to use an approved device in any manner they

see fit, may dissuade the sponsor of an already approved

product from seeking formal FDA approval

for additional clinical indications.

In practice, the new device regulatory system has

produced a climate in which cutting-edge technology

frequently lacks FDA approval for any indication or

for the indication for which the technology is being

used. Physicians, particularly those in procedurebased

specialties, are often faced with clinical circumstances

in which a reasonable course of treatment

involves use of a non-FDA approved device. These

clinical demands are widely believed to have led to

significant use of non-FDA approved devices, which

raises the question of what patients should be told

regarding the regulatory status of devices used in

their care.

Informed Consent and Non-FDA

Approved Devices

It is well established that competent adults have the

legal right to control their medical care, a concept

embodied in the doctrine of informed consent. In the

context of non-FDA approved medical devices, the

question becomes whether the regulatory status of

those devices must be regularly included in the consent


Basic Concept of Informed Consent

The adequacy of any informed consent is dependent

on state law. The majority of states employ a

reasonable practitioner standard to assess the consent

process, a standard that asks what a reasonable practitioner

would have disclosed to the patient in similar

circumstances. This standard is generally established

by physicians testifying as experts. A growing minority

of states use a reasonable patient standard, which

focuses on what information a reasonable patient in

like circumstances would need to know to make an

informed decision. The latter standard is generally

considered more demanding, as it effectively takes

the act of establishing the standard from the physician

and places it with the jury or judge. Importantly,

neither standard demands that all known information

on a procedure be revealed to the patient.

In addition to legally adequate consent, a plaintiff

must also show at trial that the inadequate consent

led to injury and to actual damages. In practice, this

means that informed consent is usually only an issue

when there has been an unfavorable outcome for the


Case Law: Informed Consent and Non-FDA

Approved Devices

We are unaware of any major reported cases involving

informed consent and non-FDA approved

devices used in radiology. An analogy, however, may

be drawn to ongoing litigation involving pedicle

screws, which are orthopedic devices commonly used

in spinal fixation. In the mid-1980s, these products

were twice submitted to the FDA under section

510(k) for use as spinal fixation devices. Twice the

application was refused, with the agency on at least

one occasion citing potential safety problems (4). The

manufacturer subsequently resubmitted a 510(k) application

that labeled the devices generic bone screws,

substantially equivalent to existing devices. With this

generic labeling, the FDA found the product was

substantially equivalent and sanctioned its marketing.

Despite the lack of specific FDA approval for spinal

use, the screws were commonly used off-label for

spinal fixation (5). A considerable number of patients

1816 SMITH AJNR: 19, November 1998

unsatisfied with their results filed suit, often claiming

that they were never informed of the device’s regulatory


A federal class action suit addressing pedicle screws

is being litigated in the Federal District Court for the

Eastern District of Pennsylvania (In re Orthopedic

Bone Screw Products Liability Litigation). As part of

this litigation, the court examined the informed consent

issue. In doing so, it applied Pennsylvania law,

which follows a reasonable patient standard: a provider

must inform a patient of “those risks which a

reasonable man would have considered material to

his decision whether or not to undergo medical treatment”

(6). The court noted that FDA regulatory

status does not speak directly to the medical issues

surrounding a particular procedure. It dismissed extensive

FDA informed consent requirements for clinical

device trials as a regulatory consequence of being

engaged in clinical trials, not a part of the basic

doctrine of informed consent. Finally, the court observed

that off-label use of a medical device is a

matter of medical judgment on the part of a physician,

adding that a physician cannot be held liable for

failing to advise a patient as to the regulatory status of

a device. In conclusion, the court found that Pennsylvania

law did not require that the FDA status of a

device be revealed as part of the informed consent


Two years earlier, however, the same Federal District

Court, again applying Pennsylvania law, suggested

a different result in the case of a patient who

underwent a diskectomy and fusion with pedicle

screws, a procedure later shown to be medically unnecessary

(7). While not rendering a final judgment

on the facts of the case, Corrigan v Methodist Hospital

held that use of a non-FDA approved device may

represent a risk that should be addressed in the informed

consent process. Notably, the court (In re

Orthopedic Bone Screw Products Liability Litigation)

specifically disagreed with this result.

Other courts are also split on this issue. In Klein v

Biscup, the pedicle screws were implanted into a patient

without any mention of their regulatory status.

Here, an Ohio court held that the FDCA does not

regulate medicine, and that once a product has been

approved for marketing it may be used by a physician

in a manner that differs from its approved use (8).

Faced with a similar situation, a Tennessee court in

Shadrick v Centennial Medical Center held that disclosure

of a device’s regulatory status is a question of

fact to be decided by a jury (9). The latter case was

decided in a jurisdiction that uses the majority reasonable

practitioner standard.

Analysis: Informed Consent and Non-FDA

Approved Devices

The cases cited above demonstrate the legal uncertainty

that currently surrounds informed consent and

non-FDA approved devices. Although In re Orthopedic

Bone Screw Products Liability Litigation appears to

represent the view of most courts that the regulatory

status of devices is not material to the informed consent

process, the outcome in any given case is likely to

be dependent on the particular facts before the court.

Such case-specific factors may include the regulatory

status of the device (ie, approved for another indication

or lacking any approval), the clinical indication in

question, and support in the medical literature for the

nonapproved use. The number of factors and their

complex interaction make the outcome in any given

case, whether in a reasonable provider or a reasonable

patient jurisdiction, difficult to predict.


The FDCA, as modified by the MDA, has created

a comprehensive system for the regulation of medical

devices to ensure their safety and effectiveness. An

unintended consequence of the system appears to be

the use of non-FDA approved devices in clinical practice.

Where such devices are employed, it is uncertain

what a patient should be told as part of the informed

consent process. Given this uncertainty, a prudent

approach may be to consider informing the patient of

the regulatory status of a device. This is particularly

true when a device lacks any FDA approval. Such an

approach may serve to prospectively address a potential

legal pitfall in the clinical use of such devices.



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