The FDA’s Center for Devices and Radiological Health (CDRH—you can follow them on Twitter) will hold a free public meeting to address concerns and discuss strengthening of the 510(k) process. The agenda includes:
- Issues related to predicate devices;
- Issues related to new technologies and scientific evidence;
- Issues related to practices CDRH has adopted in response to the high volume of 510(k) submissions; and
- Issues related to postmarket surveillance and new information about marketed devices.
The FDA receives over 3,000 510(k) submissions every year. “A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device (21 CFR 807.92(a)(3)) that is not subject to PMA.” After much backlash last year about FDA scientist/employee complaints about corruption, safety problems, conflicts of interest, and budgeting, the Institute of Medicine (IOM) was called on to comprehensively study (to the tune of $1.3 million) the 510(k) process. That study is expected to be completed in March 2011, but this meeting is a companion to that study.
- Time/Location: 8:00 a.m. to 5:30 p.m.; Hilton Washington DC North/Gaithersburg; 620 Perry Parkway; Gaithersburg, Maryland 20877.
- Live webcast
- The FDA’s Press Release
- Notice of the Public Meeting
- Background information of 510(k) process
- Announcement of the Institute of Medicine’s study of 510(k) process
This meeting is another good step the administration has taken to put patient safety first and to rigorously watch over the medical device regulatory process.