What guidance does FDA provide to the companies that make breast implants?
FDA publishes guidance documents that describe FDA’s current thinking on a topic and contain recommendations for companies . Although guidance documents are often helpful to companies, they do not create legal requirements, and their recommendations do not bind or require a company to take any specific steps. Many guidance documents advise companies how to test their products. Other guidance documents describe how companies should prepare their applications and how FDA monitors products once they are on the market. FDA issued a guidance document on breast implants called “Saline, Silicone Gel, and Alternative Breast Implants.” It describes the types of information that breast implant companies should submit to FDA when seeking approval of a breast implant so that we can assess whether or not there is a reasonable assurance that the device is safe and effective. The latest version of the breast implant guidance document was published in November 2006 and reflects information learned fro
FDA publishes guidance documents that describe FDAs current thinking on a topic and contain recommendations for companies . Although guidance documents are often helpful to companies, they do not create legal requirements, and their recommendations do not bind or require a company to take any specific steps. Many guidance documents advise companies how to test their products. Other guidance documents describe how companies should prepare their applications and how FDA monitors products once they are on the market. FDA issued a guidance document on breast implants called “Saline, Silicone Gel, and Alternative Breast Implants.” It describes the types of information that breast implant companies should submit to FDA when seeking approval of a breast implant so that we can assess whether or not there is a reasonable assurance that the device is safe and effective. The latest version of the breast implant guidance document was published in November 2006 and reflects information learned from
