Report: FDA’s Medical Device Approval Process Is Flawed

Source: Click here

MINNEAPOLIS (WCCO) – More than 100 medical devices have been recalled after a report showed that the U.S. Food and Drug Administration (FDA) process of approving them is flawed.

Some of the recalled devices have caused serious harm to patients, even death.
Katherine Ayers had one of those recalled devices implanted into her body.

She had hip replacement surgery five years ago, and she was doing great until her implant was recalled.

Metal from the hip transplant started eroding in her body, and she had to undergo a second surgery six months ago.

“Having to have a bigger incision and have more things cut into again… it just was a lot longer recovery,” Ayers said.

Ayer’s implant was approved through the FDA’s 510 (K) process, a program the Institute of Medicine now finds flawed.

Devices get approved faster in the FDA process, because companies just need to show their devices are similar to ones already on the market.

A recent study shows more than 100 devices were recalled between 2005 and 2009, affecting tens of thousands of patients.

The Advanced Medical Technology Association, whose members produce medical devices, disagrees with the report and says abandoning the current program would be a disservice to patients and public health.

Related articles

• Report could sway FDA device review process (earlsview.com)
• Barry Meier – Study Faults Approval Process for Medical Devices (earlsview.com)
• FDA 510K Process – Another Issue – Risky pelvic mesh highlights worries about FDA process (earlsview.com)
• Barry Meier – Study of Medical Device Rules Is Attacked, Unseen (earlsview.com)
• Institute of Medicine – Public Health Effectiveness of the FDA 510(k) Clearance Process (earlsview.com)
• 510(k) reforms: FDA downplays the impact of the IOM study on the eve of its release (earlsview.com)
• Regulatory Reform Series #5 – FDA Medical Device Regulation: Impact on American Patients, Innovation and Jobs (earlsview.com)
• U.S. advisers call for overhaul of FDA device approval process (msnbc.msn.com)
• FDA medical device review times to be subject of House hearing (earlsview.com)