MedEsthetics magazines offers business education and in-depth coverage of the latest noninvasive cosmetic procedures for physicians and practice managers working in the medical aesthetics industry.
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54 SEPTEMBER 2014 | Med Esthetics SAFE & EFFECTIVE The process used by the U.S. Food and Drug Administra- tion (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 benefi ts 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 benefi ts 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 ef- fective 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 submis- sion 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 dis- tributors (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 cat- egory, requiring more work and supporting documents for approval. Examples include powered wheelchairs, some pregnancy test kits and most aesthetic lasers. "The FDA requires a comparative analysis to devices already on the market," says Daniel Kamm, principal engineer for Kamm & Associates, an FDA consulting fi rm for device manufacturers. It takes roughly three to six months before approval is granted, and it's up to the manufacturer "to show through test reports that it's at least as good as what's on the market," says Kamm. Class III devices are defi ned by the FDA as those that usually sustain or support life, are implanted or present potential unreasonable risk of illness or injury. Examples of Class III devices include pacemakers and breast im- plants. According to the FDA, 10% of medical devices fall under this category. These devices require clinical trials for approval. "It can take years and hundreds of thousands of dollars to be approved," Kamm says. "It can be a very expensive and time-consuming process. The device is put through the paces to demonstrate what its effect is on patients to see if it's safe and effective." When trying to bring a device to market, a manufactur- er fi rst needs to determine the class to which the device belongs. The FDA provides two ways to discover how FDA approval means that the agency has concluded that the benefi ts of an approved item exceed the potential risk for its planned use. Most injectable fi llers are considered implants and classifi ed as Class III devices by the FDA. © GETTY IMAGES