News & Press: Latest News

MDMA Statement on FDA’s Plan to Modernize the 510(k) Regulatory Pathway for Medical Devices

Monday, November 26, 2018  
Share |

MDMA Statement on FDA’s Plan to Modernize the 510(k) Regulatory Pathway for Medical Devices

 

Washington, D.C. – Mark Leahey, President and CEO of the Medical Device Manufacturers Association (MDMA), issued the following statement today in response to FDA’s plan to modernize the 510(k) regulatory pathway for medical devices:

 

“As MDMA reviews the FDA’s proposal to modernize the 510(k) pathway for medical devices, we look forward to working with various stakeholders to maintain the agency's gold standard of protecting patients, and to ensure that Americans have timely access to safe and effective medical technologies.

“While the medical device community considers even one adverse outcome unfortunate, and we constantly strive for perfection, we must be vigilant that any changes made to a system that has worked so well for so many patients carefully balances safety and innovation, and does not adversely impact America’s innovators as they seek to improve patient care.”

 

###