FDA Safety and Innovation Act (FDASIA)
Se aprueba nueva regulación FDA:
Today President Obama signed the FDA Safety and Innovation Act (FDASIA). This law includes the Medical Device User Fee Amendments of 2012 (MDUFA III) as well as other medical device provisions. MDUFA III will be in effect for five years beginning October 1, 2012. It includes performance goals and user fees paid to the Food and Drug Administration (FDA) by medical device companies when they register and list with the FDA and when they submit an application to market a medical device in the U.S. With the additional funding, the FDA will be able to hire more than 200 full-time-equivalent workers by the time the agreement expires. Other provisions of FDASIA will change the way the FDA approves clinical trials, provide a new de novo pathway for risk-based classification of devices, expand FDA’s postmarket surveillance capabilities, shorten timelines for scheduling appeals meeting and issuing decisions, and change the process for reclassification of devices.
This law is the result of more than a year of public input and negotiations with industry representatives and patient and consumer representatives.
For more information, please see https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/ucm310927.htm.