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FDA device registration
For a limited time only, UReg FDA Registrations is offering two labels for $1,000. UReg FDA Registrations provides services for a wide range of clients who need to register and remain compliant with the many FDA rules and regulations. Contact us at 786.384.5694 to learn more.  The FDA oversees the regulation of several products: Food...
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Pharmaceuticals and over-the-counter (OTC) medications are the most regulated products. Under the Food and Drug Administration Amendments Act of 2007 (Public Law 110-85) (FDAAA), drug establishments must register and list information for drugs to be submitted electronically unless they are given a waiver. All drug establishments, both foreign and domestic, are required to register their...
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Color additives such as what you see in many foods and beverages are dyes, pigments, and other substances that alter the color of a food, drug, or cosmetic item (or even the human body). Common items that contain dyes are fruit punches, toothpaste, cough syrup, and cereal.  The FDA states that color additives are safe...
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Accuracy in labeling a product is one of the most important elements a company must incorporate into its product labeling. Claims and warnings for potential allergens (such as announcing the product was made in a facility that also processes peanuts, or it may contain soy). The Consumer Protection Act of 2004 states that companies must...
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The SmartFuse, Intelligent Implants Ltd.’s new orthopedic implant, has been cleared for use by the Food and Drug Administration (FDA) through FDA device registration. The technology remotely stimulates and controls bone growth and monitors for clinical decisions that can be made instantaneously. The new device is clear for first use in patients who need lumbar...
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SleepCogni is now registered for medical use by the Food and Drug Administration (FDA). The device is data-supported, targeting those who suffer from insomnia, and aims to break cognitive cycles that prevent sleep. Preliminary analysis shows that the device does, in fact, reduce insomnia (as measured by Insomnia Severity Index) within seven days of use...
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The Food and Drug Administration recently announced that a Nevada-based water bottle company Real Water Inc. will need to stop operations until they comply with the Federal Food, Drug, and Cosmetic Act (FD&C Act) along with other requirements.  The FD&C Act is a set of laws that oversees food safety, drugs, medical devices, and cosmetics,...
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The Food and Drug Administration (FDA) has announced that United States Marshals have seized more than 207,000 units of dietary supplements and bulk dietary ingredients that either contain or are solely kratom. Kratom, a tropical tree native to SouthEast Asia, contains compounds that cause psychotropic mind-altering effects. While it is not fully illegal, it is...
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Any Florida or Miami native knows how powerful hurricanes can be and the destruction a heavy hurricane season can bring. Long power outages and flood dangers pose a threat not only to your property but also to your food. Having a well-secured plan can help you and your family be well prepared for the risk...
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COVID-19 has been the main priority in the last year for the Food and Drug Administration (FDA). However, another critical role they are looking to bring more light to is preventing toxic chemicals from making their way into our food.  While President Biden has yet to nominate a new commissioner for the FDA, scientists and...
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