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Information on Selected FDA Activities

FDA’s mission statement indicates that FDA is to protect the public health by, among other responsibilities, ensuring that human drugs are safe and effective and that there is reasonable assurance of the safety and effectiveness of medical devices intended for human use. To achieve these goals there are various FDA requirements that must be met before a human drug or medical device can be legally sold in the United States.  In addition, there are FDA quality standards that mammography facilities must meet to facilitate the detection of breast cancers in their earliest, most treatable stages.  More information on FDA-related topics can be found by visiting the links below:

Drugs:

• Center for Drug Evaluation and Research Handbook
• FDA Consumer Magazine article, "New Drug Development in the United States"

Medical Devices:

• Getting To Market  With A Medical Device
• Device Advice

Mammography:

• About the Mammography Quality Standards Act (MQSA)
• The Policy Guidance Help System
• Listing of MQSA Certified Facilities

CMS (formerly Health Care Financing Administration) Coverage Policies

Frequently Asked Questions

Communicating with FDA

Back to FDA/CMS Gateway Page

Updated 6/19/2001

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