FDA

June 5, 2020 — The following speech was delivered by Stephen M. Hahn, M.D., Commissioner of Food and Drugs - Food and ...

March 25, 2020 — According to a statement on March 24 from Commissioner of Food and Drugs - Food and Drug Administration ...

February 16, 2020 — The following statement was issued by the U.S. Food and Drug Administration (FDA) on February 14 ...

The U.S. Food and Drug Administration (FDA) announced it is building the foundations of a national evaluation system to generate better evidence more efficiently for medical device evaluation and regulatory decision-making. The agency said a national evaluation system would generate evidence across the total product lifecycle of medical devices by strategically and systematically leveraging real-world evidence, and applying advanced analytics to data tailored to the unique data needs and innovation cycles of medical devices.

The U.S. Food and Drug Administration (FDA) reports that it has reached an agreement with Lancaster Breast Imaging of Lancaster, Pennsylvania, in regards to a Mammography Quality Standards Act (MQSA) violation self-reported by the facility. Lancaster Breast Imaging is still performing mammography to date.