As a skin care professional, does a device’s FDA credentials really make a difference? Isn’t the FDA something doctors deal with? For treating the superficial layers of the skin, do devices with FDA credentials work any better than those that don’t? Don’t FDA credentials just make devices more expensive? All great questions for today’s skin care professional.
The Food and Drug Administration (FDA) is an agency within the United States Department of Health and Human Services (HHS). It consists of the Office of the Commissioner and four directorates overseeing the core functions of the agency – Medical Products and Tobacco, Foods and Veterinary Medicine, Global Regulatory Operations and Policy, and Operations. The FDA is responsible for protecting the public health by assuring safety and effectiveness.
The FDA regulates any medical claims made by device manufacturers. Accordingly, before any medical claims can be legally made by a device manufacturer, those claims must be reviewed by the FDA for both efficacy and safety. The FDA does not test devices themselves, however, they thoroughly analyze the data submitted by manufacturers or sponsors to ensure that the claims being made about the device are substantiated and that users of the products can expect effective and safe performance – relative to the claims.
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FDA CLEARANCE
Having a medical device cleared by the FDA is a rigorous, time-consuming, and expensive process. Medical device manufacturers that pursue FDA clearance are demonstrating to the public their commitment to providing safe and effective products. Essentially, they are putting their money where their mouth is. As such, devices that are granted FDA-clearance are made by companies who have the public interest in mind and don’t try to circumvent federal regulations in taking their products to market.
By choosing FDA-cleared medical devices you are assured that appropriate regulation and authoritative oversight has been conducted. FDA clearance means that the device you are purchasing has been confirmed efficacious and safe when used as directed. In order for a medical device to receive FDA-clearance, each component of the device must pass inspection, including each of its sources, suppliers, and manufacturers. Without FDA regulation, neither the device itself nor its suppliers are held accountable to quality controls or manufacturing standards, resulting in a product that may be considerably less effective and oftentimes significantly less safe than FDA-cleared devices.
Historically, the regulatory hurdles in Europe have been easier to clear, requiring less specific clinical data, compared to the FDA. However, starting in 2021, the European Medical Device Authorities will be harmonizing their registration standards along the lines of the FDA. As such, clearing registration hurdles like the FDA is going to be required of all medical devices in Europe. That makes devices already cleared by the FDA likely compliant with the new, more stringent Europe registration requirements.
Globally the FDA is viewed as being at the forefront of regulatory standards and regulations, monitoring, compliance, and guidance for the medical device industry. Currently and continually, this is evidenced by a harmonization of international and FDA standards and regulations. The FDA’s responsibilities extend to the 50 United States, the District of Columbia, Puerto Rico, Guam, the Virgin Islands, American Samoa, and other United States territories and possessions.
CLASS CATEGORIES
In reviewing the safety and efficacy of medical devices, the FDA categorizes devices into three distinct classes. Class I is for devices where no medical claims are made and there is a low risk in using the device. The classic example of a Class I device is a tongue depressor. Class II is for devices for which medical claims are made and there is a moderate risk in using the device. Most devices used by skin care professionals are Class II devices. The successful FDA review of Class II devices results in the FDA clearance of the device.
Class III devices are typically invasive, resulting in the disruption of vital tissue, including implantable devices. The successful FDA review of Class III devices results in the FDA-approval of the device. Accordingly, a skin care professional will likely never use an FDA-approved device and should be very suspicious of anyone claiming that a device for skin care professionals is FDA-approved.
Using FDA-cleared devices in a skin care business ensures that the device has been rigorously reviewed by the agency for safety and effectiveness. That being the case, you can rest assured that the results being claimed by the manufacturer can be reproduced in your practice. FDA-clearance also serves to differentiate you from other skin care clinics in your area and will leave your clients with a greater sense of confidence in your professional choices. The bottom line, there are many advantages to using FDA-cleared devices and no real downside.
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Pam Cushing is a registered nurse with over 35 years of experience in emergency medicine. She has worked in the field of aesthetics for over 15 years, full-time for the last five years. Cushing holds a degree at the master’s level, with commendation, as well as a post-graduate diploma in aesthetic medicine, with merit. She is an independent nurse prescriber in the United Kingdom. Cushing is a consultant educator for a couple of companies educating in injectables, skin resurfacing and chemical peel, microneedling, and LED. She thrives on being able to educate, motivate, and encourage others to grow and develop professionally. She is passionate about skin and the benefits of aesthetics in improving the confidence and quality of lives. Cushing believes our key role is to educate the consumer on appropriate treatment modalities with the focus on maintaining skin health.
