FDA Regulatory : Medical Device Bans
What is a Medical Device Ban?
A medical device ban is a total prohibition on the current and future sales, distribution, and manufacturing of a medical device.
The FDA has the authority to ban a medical device intended for human use if it finds, on the basis of all available data and information, that the device presents a substantial deception to patients or users about the benefits of the device, or an unreasonable and substantial risk of illness or injury, which cannot be corrected by a change in the labeling. (see Section 516(a) of the Federal Food, Drug and Cosmetic Act; 21 CFR 895.20)
How Often Does the FDA use this Authority to Protect Public Health?
The FDA very rarely acts on this authority. Until 2016, the FDA banned only one other medical device, prosthetic hair fibers. The FDA found there was no public health benefit to this device. This device presented a substantial deception to patients or users about the benefits of the device. The prosthetic hair fibers did not stimulate hair growth nor conceal baldness, but could actually cause serious infections, illness, and injuries from their implantation. We believed that the labeling and advertising materials directly or implied misrepresented the device as safe, effective, and causing little or no discomfort, among other misleading claims.
On December 19, 2016, the FDA published a final rule banning powdered gloves based on the unreasonable and substantial risk of illness or injury to individuals exposed to the powdered gloves. The risks to both patients and health care providers when internal body tissue is exposed to the powder include severe airway inflammation and hypersensitivity reactions. Powder particles may also trigger the body's immune response, causing tissue to form around the particles (granulomas) or scar tissue formation (adhesions) which can lead to surgical complications.
For a detailed description of the risks that the FDA identified, please refer to the final rule. There are other surgical and patient examination gloves available that provide the same level of protection, dexterity, and performance without posing the same risks to patients and health care providers.
The final ban is effective for powdered surgeon’s gloves, powdered patient examination gloves, and absorbable powder for lubricating a surgeon’s glove that are already in commercial distribution and for these devices that are already sold to the ultimate user, such as small medical practices and hospitals, on January 18, 2017.
On March 4, 2020, the FDA published a final rule to ban electrical stimulation devices (ESDs) used for self-injurious or aggressive behavior because they present an unreasonable and substantial risk of illness or injury that cannot be corrected or eliminated through new or updated device labeling.
ESDs administer electrical shocks through electrodes attached to the skin of individuals to attempt to condition them to stop engaging in self-injurious or aggressive behaviors. Many people getting exposed to these devices have intellectual or developmental disabilities that make it difficult to communicate their pain or consent. A number of significant psychological and physical risks associated with the use of these devices, including depression, anxiety, worsening of self-injury behaviors and symptoms of posttraumatic stress disorder, pain, burns, and tissue damage. In addition, there is a risk of errant shocks from a device malfunction. As these risks cannot be eliminated through new or updated labeling, banning the product is necessary to protect public health. The ban does not apply to ESDs used to create aversions to other conditions or habits, such as smoking. For a detailed description of the risks that the FDA identified, please refer to the final rule.
What Process Does the FDA Follow to Ban a Medical Device?
The FDA makes the determination to ban a device by analyzing and weighing the risks and benefits the device poses to individuals. This analysis may include:
Identifying and studying the device, including assessing adverse events,
Analyzing the risks and benefits posed by alternative devices and treatments being used in current medical practice,
Analyzing whether a change in labeling on the device mitigates the risk,
Evaluating the medical literature,
Conducting a panel meeting with outside experts,
Discussing concerns with professional societies, and
Reviewing information from health care professionals and patients.
The FDA can ban a device without actual proof of illness or injury, and only needs to find that a device has the potential to present the required degree of risk based on all available data and information.
The FDA may initiate proceedings to ban the device if:
the device presents substantial deception in the labeling or an unreasonable and substantial risk of illness or injury, and
such deception or risk cannot be, or has not been, corrected or eliminated by labeling or a change in labeling.
If the FDA decides to initiate proceedings to ban a device, a notice of proposed rulemaking is published in the Federal Register.
List of Medical Device Bans
The list below contains bans that have been proposed or issued.
What is the Difference between a Proposed and a Final Ban?
A proposed ban is the FDA's statement of intent to ban a device.
In a proposed ban, the FDA outlines its assessment of the benefit-risk profile of the device. Specifically, a proposal to ban a device requires a summary of the:
Agency's findings regarding substantial deception or the unreasonable and substantial risk of illness or injury;
Reasons why the FDA initiated the proceeding;
Evaluation of the data and information the FDA obtained under provisions (other than section 516) of the FD&C Act, as well as information submitted by the device manufacturer, distributer, or importer, or any other interested party;
Consultation with a panel of experts that classify a device, if conducted (see the Advisory Committee webpage for more information about FDA Panel Meetings);
Determination that labeling, or a change in labeling, cannot correct or eliminate the deception or risk;
Determination of whether, and the reasons why, the ban should apply to devices already in commercial distribution, sold to ultimate users, or both; and
Other data and information the FDA believes are pertinent to the proceeding.
The public can comment during the comment period, which is at least 30 days.
Special Effective Date
In some cases, the FDA can put a special effective date in the proposed ban which puts the ban immediately into place as soon as it is published in the Federal Register.
This procedure may be used when the FDA determines that the potential or actual injury involved is serious enough that the agency believes will endanger the health of individuals who have been, or will be exposed to the device. For a proposed ban with a special effective date, the FDA will finalize the rule by affirming, modifying, or revoking the proposed rule. Even if the proposed ban has a special effective date, the public can comment during the comment period. Interested persons may request an informal hearing to discuss the ban.
A final ban is the FDA's statement of action and tells the public what device the FDA is banning and when that ban will go into effect.
The FDA considers any comments it receives on the proposed ban and determines whether to affirm, modify, or revoke the proposed regulation. If the proposal is affirmed or modified, the FDA will publish a final regulation banning the device. In this case, the device can no longer be legally marketed on or after the date of publication of the final regulation, except under an approved investigational device exemption. If the proposed regulation is revoked, the FDA will publish a notice to this effect in the Federal Register.
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