ABSTRACT
Chapter 1 listed major hyaluronan (HA)-based products approved so far by the U.S. Food and Drug Administration (FDA; Table 1.1). Chapter 5 provided more detailed information with regard to their compositions, sources, formulae, and indications (Tables 5.1-5.5). Safety and effectiveness are the two essential requirements for a medical device to gain the regulatory approval from the FDA. It is understood that all HA products that passed the premarket scrutiny of the FDA were deemed safe and effective for their indicated use at the time of approval. The challenge to the products, however, continued after they officially entered the market. The extensive application of a product in a real, broad market place is the ultimate validation of the usefulness of the product. The customers as well as clinicians, engineers, and scientists continue to examine to what extent the HA products actually meet the rationale and expectation of their original design. How effective is an HA-based product in comparison with its alternatives for its intended use? How beneficial is that product, in balance with its potential risk and economic cost? How sound is the scientific rationale behind the product design and development?
