Tags

, , , , , , ,


Report: IOM review of the FDA 510(k) process due Friday

July 27, 2011

by Brendon Nafziger, DOTmed News Associate Editor; Source – click here

The Institute of Medicine‘s long-awaited review of the Food and Drug Administration’s medical device approval process is due Friday, Reuters reports.

The IOM’s report is expected to suggest reforms for the FDA’s 510(k) clearance process. This so-called “fast-track” process mostly applies to moderate-risk, Class 2 devices, such as most radiological equipment. Under this process, devices get cleared for the market merely by showing “substantial equivalence” with a currently available device.

But the 510(k) process has been controversial both with industry lobbies and patient advocates. Device manufacturers feel the process has slowed recently, and that rulings are often arbitrary and inconsistent. Patient advocates complain that dangerous or unproven products can get whisked through without proper testing.

Last year, the FDA proposed a series of its own reforms to the 510(k) process, in an attempt to please both groups. The agency intends to create a new category, Class 2b, for slightly riskier devices, and also require the clearance process to be more transparent.

The IOM, famous for revamping hospital safety with its 1999 report, “To Err Is Human,” was tapped by the FDA to review the 510(k) process in September 2009.

  • FDA clarifies when medical device changes call for new 510(k) submission (medcitynews.com)
  • FDA: Agency has included industry perspective on 510(k) review (medcitynews.com)
  • Sadwin Raises More Questions – Will They Ever Be Answered? (earlsview.com)
  • FDA medical device review times to be subject of House hearing (earlsview.com)
  • Medical device review times slow, but companies share blame, FDA says (medcitynews.com)
  • FDA predictability a top concern for medtech firms; EU preferred for product approval (eurekalert.org)
  • Is the FDA softening its stance on a medical device approval overhaul? (medcitynews.com)
  • Small medical device companies shorted by FDA 510(k) review, study says (medcitynews.com)
  • RPS announces FDA 510(k) clearance for RPS Adeno Detector Plus™ (prweb.com)
  • Despite Early “Victories,” Medical Device Industry Continues To Face Uphill Slog in Washington DC (xconomy.com)
  • FDA Grants TM-400 Orphan Drug Designation For Mobilization Of Stem Cells Used To Treat Hematologic Cancer In The U.S. (bioresearchonline.com)