Requirements

Clinical evidence is required to assure the safety and efficacy of a medical device for intended use pre-market. After an appropriate risk-benefit analysis, the device may still be placed on the market with the residual risk. The questions about residual...

The Food Safety and Modernization Act (FSMA) was signed into law in 2011, with compliance dates for some businesses beginning in 2016. However, because of the extent of reform, FDA is still working on providing guidance documents and tools that...

Colors can set apart your medical device, drug, food, and cosmetic. But, do you know how FDA permits their use within the US? This blog article reviews the regulations and processes in place for color additives. Color additives, artificial color, or...

The U.S. Food and Drug Administration is offering another opportunity for stem cell clinics to work with the Agency and understand the regulatory framework. Will it work this time around? This blog article recaps how we got to this point. Stem...

The $40 billion dietary supplement industry is still growing making it a market you may want to take advantage of, but FDA’s oversight of these products is also increasing1. FDA currently regulates dietary supplements Under the Dietary Supplement Health and Education...

FDA has issued a proposed rule to up classify surgical staplers for internal use as class II medical devices, subject to special controls and pre-market notification. Currently, both internal and external surgical staplers are classified as class I, subject to...

Post-Market Surveillance (PMS) is required for medical devices. There are two types of post-market surveillance – reactive and proactive. Reactive is the most common approach used when setting up a PMS system, but that doesn’t mean a proactive approach isn’t...

On numerous occasions, we have seen companies’ websites and products boasting with an FDA approved stamp on it. While the FDA is responsible for protecting public health by regulating drugs, medical devices, tobacco, food, cosmetics, and radiation-emitting products; it does...

The Unique Device Identification system is used to identify the device throughout its distribution and use on the market. This system enables efficient post-market surveillance for medical device companies as well as for the FDA. FDA released a final guidance...