Medical devices aren’t simply regulated – they are also subject to rigorous testing and review processes to ensure their safety and their compliance with specific rules. Who or what is responsible for this? In the United States, the Food and Drug Administration (FDA) regulates the sale of all medical device products. First, before a medical device can be legally sold and distributed in the U.S., the person or company wanting to sell the device must apply for and seek the FDA’s approval. To gain approval, they must present evidence that the device is reasonably safe and effective for a particular use (U.S. Food and Drug Administration). Ultimately, there can only be sales when a medical device has the FDA’s clearance.
Regulatory Responsibility
The FDA has the responsibility of regulating a broad range of medical devices. From complex, high-risk medical devices like artificial hearts to relatively simple, low-risk devices like tongue depressors, the FDA has the authority to continually regulate all medical devices even after they become available to medical professionals. While there are hundreds of thousands of devices in the marketplace today, only one arm of the FDA handles all regulation. The FDA’s Center for Devices and Radiological Health (CDRH) regulates any company that designs, manufactures, repackages, relabels, or imports medical devices into the U.S. Even though the FDA has a lot of authority in the medical device industry and, therefore, lots of influence within the medical and pharmaceutical industries, there are certain things the FDA can’t do. These include but are not limited to:
- Regulating a physician’s practice. The FDA cannot tell providers how to run their businesses or influence what they tell their patients.
- Making recommendations for individual doctors, hospitals or clinics, or providing treatment options.
- Conducting or providing rating or review systems for any regulated medical devices.
Classifying Medical Devices
The FDA classifies all medical devices based on the device’s associated risks. Each device is subject to fall into one of three categories.
Class I devices are considered low risk and are, therefore, subject to the least amount of regulatory controls. These “general controls” devices may include dental floss, elastic bandages, and hand-held surgical instruments, etc.
Class II devices are considered medium risk. Since they are higher risk devices than Class I, they require greater regulatory controls to provide reasonable assurance of their safety and effectiveness. Examples of Class II products are infusion pumps, air purifiers, acupuncture needles, and powered wheelchairs.
Class III devices are high-risk devices and are subject to the highest level of regulatory control. Class III devices are usually those that support or sustain human life, are of substantial importance in preventing human health impairment, or present a potential risk of illness or injury. Additionally, before these devices are marketed, the FDA must approve them. Examples include implantable pacemakers, HIV diagnostic tests, pulse generators, and automated external defibrillators.
Clear and Approved Devices
Depending on the actual product itself and its classification, the FDA will either “clear” or “approve” a medical device. A “cleared” device has had its 510(k) application, which is essentially a premarket notification, filed with the FDA, reviewed, and deemed ok to proceed with marketing.
To acquire FDA clearance to market a device through a 510(k) application, the submitter must show that the medical device is “substantially equivalent” to another medical device that has already been legally marketed for similar use. Except for rare cases, the 510(k) does not require clinical trials.
An “approved” device has had a submitted premarket approval (PMA) application reviewed by the FDA. To acquire the approval of a medical device using a PMA application, the applicant must provide reasonable assurance and proof that the device is safe and effective. These assurances may include a case study or independent testing of the product. This premarket approval pathway requires clinical trials, and the process is similar to the one used for new drug approvals.
Again, a medical device product’s clearance or approval depends on the product and the product’s classification.
Ongoing Observation
The FDA program MedWatch continually monitors the current safety and efficacy of all regulated marketed devices. The FDA uses MedWatch to communicate news and updates related to safety information and adverse events associated with each product. MedWatch, also, has an online portal that allows manufacturers, health care professionals, and consumers to report serious problems related to the use of drugs and medical devices.
It’s important to learn how and why the FDA regulates medical devices by the FDA. For medical device sales reps, it can be even more important to understand the process involved in the device’s approval. If a sales rep knows the timeframe of a device hitting the market and the potential obstacles a particular product may face while waiting for approval, they are more effectual at their jobs, especially in their communication with physicians, nurses, and other medical staff.
