New drugs and medical devices may be touted as FDA approved, but exactly what does that highly valued and oft-cited stamp of approval mean? It’s a question that’s sure to come up often for physicians as they consider whether to prescribe a new treatment for their patients or bring a medical device of their own design to the marketplace.
The process used by the U.S. Food and Drug Administration (FDA) to determine if a new drug or medical device is “safe and effective” can seem complicated with different classes and tiers of approval. Some medical products are approved almost immediately, while others require decades of preclinical animal testing followed by human clinical trials.
It’s up to the manufacturer of a drug or device to prove to the FDA that the product is safe and effective. Because no medical product is entirely risk-free, the research and testing must show that the benefits of the drug or device for a particular condition outweigh the risks to patients who will use them. Thus, FDA approval means that the agency has concluded that the benefits of an approved item exceed the potential risks for its planned use.
Medical Device Approvals
There are three regulatory classes for medical devices. These tiers were created according to the level of control required to ensure that the device is used in a safe and effective manner, and according to the risk the device poses to the patient and/or end user. Class I devices pose the least risk; Class III the highest.
The class to which a device is assigned determines the FDA application process required to market the product in the U.S. If a device falls into Class I or II—and is not exempt—the manufacturer must complete a 510(k) premarket submission demonstrating that the device to be marketed is at least as safe and effective as another existing and FDA-approved medical device currently on the market. Applicants must compare their device to one or more similar, legally marketed devices and make a claim that their device is substantially equivalent to the existing product.
In addition, manufacturers (both domestic and foreign) and initial distributors (importers) of medical devices must register their establishments annually with the FDA. Foreign manufacturers must also designate a U.S. Agent to represent their product. The fee in 2014 for establishment registration is $3,313.
Class I devices present the least potential for harm to the user and are often simpler in design than Class II or Class III devices. Examples include enema kits and elastic bandages. According to the FDA, 47 types of medical devices fall under this category and 95% of these are exempt from the regulatory process.
Class II. Most medical devices fall into the Class II category, requiring more work and supporting documents for approval. Examples include powered wheelchairs, some pregnancy test kits and most aesthetic lasers.
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