Drug or Device – Who regulates your product?

The very first step towards bringing your product to the market is understanding which center at the FDA shall regulate your product. The primary centers at the FDA are: CDRH – Center for Devices and Radiological Health CDER – Center for Drug Evaluation and Research CBER – Center for Biologics Evaluation and Research Although, FDA … Read more Drug or Device – Who regulates your product?

Nutraceuticals

INTRODUCTION Nutraceuticals is a broad umbrella term that is used to describe any product derived from food sources with extra health benefits in addition to the basic nutritional value found in foods. The term “nutraceutical” combines two words – “Nutrient” (a nourishing food component) and “pharmaceutical” (a medical drug). The name was coined in 1989 … Read more Nutraceuticals

CER Requirements and Expertise

According to MEDDEV 2.7/1 Rev.4, “Clinical evaluation is a methodologically sound ongoing procedure to collect, appraise and analyse clinical data pertaining to a medical device and to analyse whether there is sufficient clinical evidence to confirm compliance with relevant essential requirements for safety and performance when using the device according to the manufacturer’s instructions for ... Read more CER Requirements and Expertise