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FDA Hearing on 510(k) Medical Device Approvals for Center for Devices and Radiological Health

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.

Conference Details:

  • Time/Location: 8:00 a.m. to 5:30 p.m.; Hilton Washington DC North/Gaithersburg; 620 Perry Parkway; Gaithersburg, Maryland 20877.
  • Live webcast

Related documents:

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.