THE WHAT? The US FDA has clarified that in-vitro diagnosis products (IVDs) are devices under the Food, Drug and Cosmetic Act, including when the manufacturer of the IVD is a laboratory.
THE DETAILS The change has been prompted by the wider use of laboratory developed tests (LDTs) for a larger and more diverse population. Furthermore, there is a growing body of evidence that demonstrates that some LDTs are inaccurate, unsafe, ineffective or poor quality, raising public health concerns.
THE WHY? FDA Commissioner Robert M. Califf, explains, “LDTs are being used more widely than ever before – for use in newborn screening, to help predict a person’s risk of cancer, or aid in diagnosing heart disease and Alzheimer’s. The agency cannot stand by while Americans continue to rely on results of these tests without assurance that they work. The final rule announced today aims to provide crucial oversight of these tests to help ensure that important health care decisions are made based on test results that patients and health care providers can trust.”
Clinical aesthetics products refer to a category of products used in the field of medical aesthetics or cosmetic dermatology. These products are typically designed and formulated to be used under the supervision of healthcare professionals, such as dermatologists, plastic surgeons, or trained aestheticians. They are distinct from over-the-counter cosmetics in that they often contain active ingredients or formulations that require expertise in their application or administration.
Examples of clinical aesthetics products include:
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Dermal Fillers: Injectable substances used to add volume, smooth wrinkles, and enhance facial contours. Examples include hyaluronic acid fillers like Juvederm and Restylane.
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Botulinum Toxin (Botox): Injectables that temporarily paralyze facial muscles to reduce the appearance of wrinkles caused by repetitive movements, such as frown lines and crow's feet.
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Chemical Peels: Solutions applied to the skin to exfoliate and improve its texture. They can treat acne, pigmentation issues, and signs of aging.
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Laser and Light Therapies: Devices that emit focused light or laser energy to treat various skin conditions, including acne, scars, and signs of aging.
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Prescription Skincare Products: Formulations containing active ingredients like retinoids (vitamin A derivatives), hydroquinone, or prescription-strength antioxidants to address specific skin concerns under medical supervision.
