Statement of Diana Zuckerman at the Meeting of the FDA Risk Communication Advisory Committee -

Even educated people don’t want to read long, complicated materials–except possibly the most highly motivated people, and even they want to get the meat of the matter, not the extraneous information. And, also remember that most medications in this country are taken by the elderly, and even those who are highly educated may not be able to read or concentrate as well as they did when they were younger.

Statement by Diana Zuckerman at the FDA's meeting on strengthening the Center for Devices and Radiological Health's 501(K) Review Process -

Clearly, the focus of the 510(k) process has been on letting companies change devices in the name of innovation, not based on public health standards or problems. As a result, devices are being sold that are so different from previous “substantially equivalent” devices that the FDA has no idea whether the product is safe or effective, and in many cases these innovative devices are either not as safe as other products on the market, or not as effective. This costs the medical system (and individuals) billions of dollars each year.