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Receive 2 Labels for $1,000 from UReg FDA Registrations

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 […]

PFAS in Food Supply

The FDA’s Total Diet Study (TDS) monitors the levels of nutrients and contaminants in food in the United States. Recently, the FDA tested 94 samples of different types of food products and only found one sample with PFAS, which was located in a piece of cod, later determined not to be of health concern.  PFAS […]

FDA FAQs About Medical Device Registration

All medical device establishments must meet certain requirements for their devices. These entities are involved in producing and distributing medical devices that will participate in commercial distribution within the United States. That also includes what will be imported only. All must register with the FDA. Some common questions when it comes to FDA medical device […]

FDA Drug Establishment Registration

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 […]

FDA Cuts Nearly a Quarter of Food Facilities From Its Database

Earlier this year, the FDA cut 59,420 food facilities from their registration database, nearly a quarter of facilities registered. Food facilities must renew their registration between October and December of every even-numbered year. If a company fails to do so, the registration they previously had expires, and they are removed from the database after the […]

Claim Labeling Requirements from the FDA

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 […]

FDA Breakthrough With Orthopedic Implants

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 […]