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High Risk Devices Still Not Reclassified


By the end of the year, the U.S. Food and Drug Administration (FDA) had stated it would make sure that high-risk medical devices were approved through the most stringent premarket approval (PMA) review process to assure the safety of consumers.

But it looks as though that will not happen.

High-risk medical devices, considered Class III, and defined as, “purported or represented to be for a use in supporting or sustaining human life or for a use which is of substantial importance in preventing impairment of human health,” or “presents a potential unreasonable risk of illness or injury.”

Some examples of Class III devices include coronary stents, endovascular grafts, percutaneous heart valves, cardiac occluders, and left ventricular assist devices (LVADs).

When the FDA began regulating medical devices in the late 1970s, about 170 high-risk devices were still being approved for market through the less rigorous 510(k) program. A fast-track approval process, 510(k) is more like a notification process. The manufacturer announces to the FDA its intention of marketing a device that is the “substantial equivalent” of one already being sold. The FDA basically rubber stamps the device for market within months.

How did high-risk devices have such an easy time being approved?

If the medical device was marketed prior to the Medical Device Amendments of 1976, it was allowed to remain Class III with no requirement for a PMA. The Safe Medical Devices Act of 1990 required the agency to either reclassify the medical devices into low-or-moderate risk Class I or II, or establish a schedule for requiring PMA, which would involve clinical trials to test for patient safety. So far that process remains incomplete.

As of 2009, the FDA had reduced the reclassification waiting list from 170 to 26. As of June 25 of this year, the FDA had not yet issued final rules on 21 of those 26 medical devices that were supposed to be reclassified.

After legislative changes were imposed, the FDA is now required to hold a meeting on a device, complete with expert panelists to finalize reclassifying the devices.

Just the other day, the FDA made some attempts.

On December 5, the FDA held an expert panel meeting to determine the reclassification of three preamendment Class III devices that are still marketed via 510(k). They are:

  • External Counter-Pulsating (ECP) devices – December 5, 2012, Session I
  • Intra-Aortic Balloon Pump (IABP) devices – December 5, 2012, Session II
  • Nonroller-Type Cardiopulmonary Bypass Blood Pump devices – December 6, 2012

All three devices were pre-Medical Device Amendments of 1976 Class III devices that were never declassified or required to go through PMA.

While it’s important to finish reclassifying potentially dangerous medical devices, the FDA has not taken the important step of reclassifying dangerous devices that belong in Class III but remain in Class II. Those would include metal-on-metal hips, defibrillator leads, transvaginal mesh and lap-bands.

Do your own research on 510(k) medical devices.

About 17 percent of Americans are living with some form of implanted medical device and most of these devices (Class I or II) have also not been required to go through the PMA process.

The FDA has a lot of work ahead of it to fulfill its mandate to protect patients and consumers from dangerous medical devices. Since about 90 percent are approved through the 510(k), if you or a loved one is facing a medical device implant surgery, you will want to know if the device went through PMA or the 510(k). If it’s the latter, you will need to be your own advocate and research the device further to make sure it’s safe. Do not assume the FDA has done this work for you.

The FDA has a long road ahead of reclassifying not just Class III but many Class II devices that also pose an “unreasonable risk of illness or injury.”

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Posted By: Clinton Cimring