The FDA regulates a wide range of medical devices, including, pacemakers,

cardiovascular stents, respiratory ventilators, breast implants, diagnostic tests and

relatively simple devices such as tongue depressors and elastic bandages.

The FDA’s system for regulating medical devices was established by Congress in 1976
with the passage of the Medical Devices Amendments to the Federal Food, Drug, and
Cosmetic Act, and has been amended several times since then. Congress established
three classes of medical devices based on the degree of control necessary to
reasonably assure that the various types of devices are safe and effective. Medical
devices are classified based on the risks associated with the use of the device: Class I,
Class II, or Class III, with Class I being the lowest risk and Class III the highest risk.
Premarket review for products is generally determined by their class categorization, with
the riskiest devices requiring premarket approval, while the lowest risk products are
generally exempt from premarket review. Low to moderate products often require a
premarket notification submission, also called a 510(k).

This classification system is designed to balance patient safety with an efficient and
effective system for regulating medical devices to enable timely patient access. The
510(k) Program has served the American public well, providing an efficient and effective
approach for patients to have timely access to tens of thousands of safe and effective
devices. A typical 510(k) application includes extensive information about the product
including information about product performance and other supporting data. In addition,
the FDA can impose additional requirements, called special controls, when necessary to
provide adequate assurance of safety and effectiveness. Special controls may include
performance standards, postmarket surveillance, patient registries, special labeling
requirements, and premarket data requirements and/or guidelines.

For example, in the case of IVC filters, manufacturers generally have to conduct and
submit clinical studies for new filters in a new 510(k) submission. In addition, all
manufacturers of currently marketed (and 510(k) cleared) IVC filters (with one
exception[4]) are currently conducting additional postmarket clinical studies of their
devices to provide greater understanding of the clinical patterns of filter usage and the
conditions that might lead to filter failures.

In response to reports of adverse events and problems associated with retrievable IVC
filters, the FDA issued safety communications, in August 2010 and in May 2014 about
device migration, filter fracture, embolization (movement of the entire filter or fracture
fragments to the heart or lungs), perforation of the IVC, and difficulty removing the
device. The FDA determined that these events were often due to doctors leaving these
filters in place long term, beyond the timeframe for which the device had been cleared
to remain implanted and when the patient was no longer at high risk for a pulmonary
embolism.

The FDA continues to monitor and assess the safety of IVC filters through reports to the
FDA and through a national IVC filter registry to study the long-term safety of these
important, life-saving devices.
The FDA uses a variety of tools to continue to assure the safety of all medical devices,
including adverse event and malfunction reports and required postmarket studies. In
addition, the FDA has been working with partners to establish the National Evaluation
System for health Technology (NEST), which would include an active surveillance
capability to identify new and increased safety risks in near real time. This and other
safety-related actions the FDA has taken, has underway, or is exploring can be found in
our April 2018 Medical Device Safety Action Plan.

Stephanie Caccomo
Press Officer

Office of Media Affairs

Office of External Affairs
U.S. Food and Drug Administration
Desk: 301.348.1956
Cell: 240.762.8873
stephanie.caccomo@fda.hhs.gov