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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 […]
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 […]
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 […]
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 […]
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 […]
The Food and Drug Administration (FDA) has been regulating good safety since its first act in 1906 – the Pure Food and Drug Act. The act was passed shortly after the publication of Upton Sinclair’s infamous novel, The Jungle, when President Theodore Roosevelt read it and was later appalled by what he learned was happening. […]
This summer, the FDA issued a warning for Little Hatch’s products as they were linked to severe health concerns. In late May, the parent company Interstate Food products voluntarily recalled Little Hatch’s Jalapeno Cream Cheese. Another recall notice was given almost a week later for queso, and in mid-June, internal testing confirmed that the salsa […]
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 […]
