The FDA has various enforcement tools at its disposal to deal with violations of an FDA regulation. The following sections provide summary information on the main FDA compliance actions and the type of penalties that may apply.
The federal agency performs many tasks in carrying out its compliance responsibilities. For instance, the FDA oversees product recalls, inspects manufacturing facilities, and monitors the implementation of preventive and corrective actions.
The FDA also conducts various activities in support of its compliance responsibilities short of taking action against a medical device. For example:
- the federal agency may hold informal, internal committee meetings to assess a particular issue of concern,
- the FDA may conduct device inquiries to determine whether more formal actions are needed,
- FDA’s laboratories may perform research in support of compliance and evaluation activities.
When a non-compliant device is discovered, the FDA has the authority to pursue various administrative actions and even resort to legal proceedings if the violation is severe enough and warrant the use of civil or criminal sanctions. The seriousness of the violation, the risks the offence may pose to the safe use of the device and the potential harm to the device user determine the type of compliance action to be taken. There are eleven FDA compliance actions worth mentioning, as follows:
#1. Untitled and Warning Letters
The issuing of an Untitled or Warning Letter is the first sign from the FDA that there is a compliance issue with a specific medical device. The recipients of these letters are individuals or entities in the US or foreign importers.
An FDA Warning Letter usually contains a list of all the actions and conditions that the agency considers violative. If the letter recipient fails to implement acceptable corrective measures, the agency may take legal action. However, if the conditions don’t rise to the level of possible legal actions, the agency typically sends an Untitled Letter to the concerned party.
#2. Mandatory recalls
If the FDA becomes aware of an issue with a marketed medical device through its own marketplace surveillance and from its own information sources, the agency is likely to request a recall of the product. If the manufacturer doesn’t comply with the request, the FDA usually orders the manufacturer to institute a mandatory recall based on the risk of injury or illness and/or gross consumer deception.
During a product recall, the FDA’s role is to review and guide the manufacturer conducting the recall. The agency monitors the process to assure that the corrections are appropriate and sufficient. The time frame for the recall activities is usually very short, often only hours or days. When the FDA determines that the recall strategy is implemented successfully, the recall is terminated.
#3. Notification, Repair, Replace or Refund
The FDA uses this compliance action to obligate a manufacturer to notify users of defective, fraudulent, or otherwise hazardous products and assure that such products in the hands of users are repaired, replaced, or refunded.
In this regard, the agency may order manufacturers, importers, or suppliers to repair, replace or refund the purchase price of a device that presents unreasonable health risks. However, beforehand, the FDA must determine that:
- the product represents an unreasonable risk of substantial harm to public health and is not designed and produced in accordance with the relevant regulations.
- the risk is not due to the device’s negligent installation, maintenance, repair, or use by the user
- notification alone is insufficient, and repair, replacement, or refund is necessary.
#4. Disqualification
Disqualification is a severe action that the federal agency doesn’t take lightly or frequently. The FDA may disqualify a person (e.g. clinical investigator), a clinical site, a test laboratory, or an IRB or its parent institution. This type of FDA compliance actions is taken in the following cases:
- Repeated or deliberate violations of the FDA’s regulations
- Repeated or intentional submission of misleading or false information to the sponsor or FDA in any compulsory report
- Failure to take adequate corrective actions to achieve compliance.
Disqualification has the following serious consequences:
- studies performed by the disqualified party would not be acceptable in support of a submission to the FDA,
- the disqualified party (e.g. clinical investigator or test lab) would not receive investigational devices,
- a disqualified IRB would not be permitted to oversee clinical trials.
To arrive at a disqualification, the federal agency must take several steps. First, based on inspectional findings, the agency needs to issue a Form 483 of observations of deficiencies. Second, failure to correct the deficiencies is followed by a Warning Letter. If the concerned party fails to take appropriate corrective actions, the FDA determines that disqualification is the proper solution. Consequently, the FDA will publish a public notice of the proposed disqualification action. Once the disqualification process is completed, the agency publishes its final decision in the Federal Register.
#5. Civil money penalties
Civil money penalties is another FDA compliance action, which is taken for violations of many device-related provisions of the FDCA. Usually, the agency can impose penalties up to $15,000 for each violation, totalling up to $1,000,000 in each proceeding. The Justice Department is responsible for collecting any unpaid civil penalties.
#6. Administrative detention
If the federal agency discovers that a device is adulterated or misbranded, the device can be temporarily detained. This administrative action temporarily prevents the device’s movement while the agency seeks a seizure order from a court of law.
Learn about the FDA 510(k) certification process
#7. Seizure
The seizure of a device is conducted under a court order. The seizure of an adulterated or misbranded medical device may happen at any time without regard to whether the device is in interstate commerce. This type of FDA compliance action may apply to:
- a specific product,
- all models of a product,
- raw materials specific to a device,
- in-process components,
- one or all lots.
The seizure usually doesn’t apply to manufacturing equipment.
#8. Embargo
The embargo is an FDA compliance action forbidding the access of a product to the US market if the device is:
- adulterated or misbranded,
- forbidden or restricted in sale in the country in which it was produced,
- forbidden or restricted in sale in the country from which it was exported.
FDA may conduct a compliance follow-up inspection after placing an import alert on a product. The purpose of the check is to confirm corrections before lifting an import alert. In some cases, the agency may first allow the importer to recondition the product in order to make it compliant with the FDCA.
#9. Injunction
An injunction is a court order obligating an individual or entity (e.g. manufacturer) to do or refrain from doing a specific act. It may involve the production or distribution of a medical device. The injunction could be:
- “preliminary”: it’s effective during a 60-day period to allow the FDA to file its complaint in court.
- “permanent”: it represents a court decree after a hearing.
#10. Criminal prosecution
Criminal prosecution is an FDA compliance action directed against a company or an individual. It may lead to fines and/or imprisonment of 1 to 10 years. Fines can run up to $15,000 per violation and up to $1,000,000 per proceeding.
#11. Consent agreement
A “consent decree” is an agreement between the federal agency and a firm or individual that contains information about alleged violations, corrective actions to be taken, applicable penalties, future conduct, and any other details necessary to resolve the issues between both parties. The consent agreement is filed in court, and if the court agrees with it, a decree embodying the consent agreement is issued. The latter is enforceable through judicial actions.
