MEDICAL ALLEY, Minn. – Medical Alley Association welcomes action taken by the Senate Health Education, Labor and Pensions Committee – approving the FDASLA Act of 2022.
The bill reauthorizes user fee agreements and includes provisions for which Medical Alley Association has advocated – including clarification to the FDA’s Certificate to Foreign Government (CFG) program and allowing predetermined change control plans (PCCP) for device manufacturers.
Roberta “Bobbie” Dressen, President and CEO of Medical Alley Association released the following statement:
“I appreciate the Senate HELP Committee advancing this important bipartisan agreement. The provisions to clarify the CFG program and allow PCCPs will continue to spur medical device ingenuity while maintaining FDA’s robust global reputation for quality and safety.
“Medical Alley Association will continue to advocate for legislation which enables our member companies to innovate and create safe and effective tools to save lives around the world every day.”
About Medical Alley Association: Founded in 1984, Medical Alley Association (MAA) represents the most diverse and influential healthcare community in the world. Our members span the full continuum of care – from payers to providers to digital health, biotech, medical device and everything in between. Our mission is to elevate the Medical Alley region as The Global Epicenter of Health Innovation and Care®.