If your primary care physician has recently prescribed or recommended a medical device (such as a pacemaker, insulin pump, or aortic stent) you may have questions about the product's safety. Fortunately, the federal government has established an agency that helps ensure the safety and effectiveness of all medical devices before they can be sold to patients. Read on to learn more about the tests a device must go through before it can be approved for sale by the Food and Drug Administration (FDA).
What does FDA approval mean for medical devices?
The federal government has granted the FDA the power to review, approve, monitor, and recall a wide variety of substances available for sale to the general public, including food, cosmetics, over-the-counter drugs, medical devices, and controlled substances.
When the FDA approves a medical device, it means that the device has been deemed both safe and effective. Often, the FDA may decline to approve a medical device (or other medication) if the benefit provided by the device does not sufficiently outweigh any potential negative side effects, or if the device provides no quantifiable benefit (even if it has no negative side effects).
The FDA approval process is a lengthy one and may require years or even decades of painstaking research and the creation of hundreds of prototypes. If your doctor has prescribed an FDA-approved device, you can rest assured that this device has been thoroughly tested for safety -- even if it has only recently been brought on the market or made available for purchase.
What testing does the FDA require before it will approve a specific device?
The FDA is a regulatory and enforcement agency -- it does not test the devices itself. However, it does require manufacturers and other companies seeking approval for proprietary devices to undergo strict testing standards to ensure the safety and effectiveness of those devices.
These standards often vary by the type and classification of the device. For example, pacemakers and other radiation-emitting devices are subject to a much different type of testing than other sorts of devices, as a potential malfunction of a radiation-emitting device could potentially harm not only the patient, but the public.
In general, a device that is believed to pose a low (or no) risk of serious side effects may be the subject of a clinical study before the FDA ever becomes aware of the device. This clinical study must follow the accepted procedures established by the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).
A device that may carry a risk of serious side effects must receive an "Investigational Device Exemption" from the FDA before it can be the subject of a clinical study to gather evidence on safety and effectiveness. This requirement provides an additional safeguard to consumers.
Speak to experts in medical device testing for more information.