Health care products
The U.S. Food and Drug Administration (FDA) regulates a wide variety of innovative health care technologies, many of which are rapidly evolving and can allow for increasingly personalized care. These products include algorithm-based diagnostic programs that can learn and change in unpredictable ways and medical devices customized and manufactured for individual patients using 3D printers. FDA oversight must adapt to keep pace with this changing field and ensure that the benefits of emerging technologies outweigh their potential risks.
Pew worked to ensure that FDA could review the safety and effectiveness of such technological advances without hindering innovations that could benefit patients.
Issue Brief August 5, 2021