Premarket review processes as prescribed by the Medical Device Amendments of 1976 to the Food, Drug, and Cosmetic Act greatly affect the use of materials in medical products, especially for implantable devices. The premarket approval process can have a particularly important role in eventual commercial medical uses of materials. Managing the process properly is often critical to the success or failure of a product.

A review of the law and regulations as they pertain to premarket approval is presented. Subjects included in this overview are prediction of process time and costs, examination of potential pitfalls in the process, recommendations on organizing for successful completion of the process and handling the relationship with FDA.

Specific materials related issues that are likely to arise are noted.