WASHINGTON The FDA guidance on when to file a new 510(k) to address changes to an existing device is still in force at FDA despite industry blow-back and vocal opposition to the guidance on Capitol Hill, said Jeff Shuren, MD, director of the Center for Devices and Radiological Health at FDA. Shuren was speaking to device makers at the annual meeting of the Medical Device Manufacturers Association (MDMA), and said that any action on this and other guidances mentioned in device user fee legislation would wait until the House and Senate reconcile the differences in their respective bills. Among the other guidances addressed in draft or final user fee legislation are the guidances for mobile medical applications and de novo device applications. Read More
