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Does the FDA adequately review medical devices?

November 12, 2014 | Category: Medical Devices | Share

The U. S. Food and Drug Administration (FDA) reports that over 200,000 injuries and up to 2,000 deaths are linked to medical devices each year.

The number of patients experiencing severe complications from medical devices such as the defibrillators, hip replacements, knee replacements, implants, contraceptive devices and transvaginal mesh are growing. The risks may far outweigh a device's potential benefits, and patients need to be aware of the risks in order to make more informed decisions about having these devices.

Defective medical devices can cause life-threatening physical injuries including those causing pain and a loss of quality of life. The trauma associated with defective medical devices also includes financial damage because of medical expenses which can be large and usually are unforeseeable. Those caring for the patient may also suffer some of these same economic losses.

Sara Murray of the Wall Street Journal reported in September that the majority of moderate-to-high-risk medical devices approved by the FDA lack publicly available scientific evidence to verify their safety and effectiveness despite requirements in the law.  Over the past five years, 42 of 50 selected medical devices cleared by the FDA contained no data to justify their FDA clearance.

FDA logo - Spivey Law Firm, Personal Injury Attorneys, P.A."Government investigators say the FDA is putting patients at risk by approving sensitive medical devices such as hip joints and heart defibrillators under the same streamlined system intended for power wheelchairs, stitches and catheters," according to Business Week .

In 1976 Congress set up a three-tiered classification system for the devices.

  • Low-risk devices like crutches and hospital beds do not require FDA review.
  • Moderate-risk devices such as mercury thermometers and power wheelchairs could be cleared by the speedy 510(k) method.  If the FDA does not object to a manufacturer's 510(k) application within 90 days, the device is automatically approved for marketing.
  • High-risk devices such as pacemakers and heart valves have to go through tighter scrutiny, and their manufacturers are required to provide studies demonstrating their safety and effectiveness. Devices classified as high-risk tend to be ones that are implanted in the body or could spell the difference between life and death. (Source: Business Week)

Medical devices are reviewed by the FDA in one of two ways:

  1. PMA - A prior-to-market approval requires clinical testing and inspections.
  2. The 510(k) process requires a new device to be similar to a device already on the market.

The second method, 510(k), according to the FDA, is meant for devices they consider to be of low or moderate risk.  Using the 510(k) application, device manufacturers can receive market approval on a fast track by simply showing that the device is "substantially equivalent" to an existing device.  This is known as a "predicate" device.  When a device is cleared through the 510(k) method, it then can serve as a "predictive" device for future 510(k) submissions.  When comparing the standard premarket approval process and the 510(k) process, the 510(k) is less stringent, less expensive, and faster.  Also, unlike the PMA applications, direct evidence of effectiveness is usually not required.

A 2011 study by the National Center of Women & Families, a health research group, and the Cleveland Clinic, as reported in the Wall Street Journal, found that of 113 medical devices that were subject to recalls between 2005 and 2009, 80 were allowed on the market through the 510(k) program.  About one third of the recalled devices were cardiovascular products, including several brands of external defibrillators.

Companies are required to provide public evidence of why their new products are really comparable to an existing one, according to the Safe Medical Devices Act of 1990.  Although not required, the evidence may include clinical trials.

"Because of the complexity of medical device product liability cases, if you or a loved one has been injured by a defective medical device, seek out a Fort Myers Medical Devices Attorney with extensive experience in medical product liability cases," recommends Attorney Randall Spivey of Spivey Law Firm, Personal Injury Attorneys, P.A.


Fort Myers Medical Devices Attorney, Randall L. Spivey is a Board Certified Trial Attorney – the highest recognition for competence bestowed by the Florida Bar and a distinction earned by just one (1%) percent of Florida attorneys.  He has handled over 2,000 personal injury and wrongful death cases throughout Florida.  For a free and confidential consultation to discuss your legal rights, contact the Spivey Law Firm, Personal Injury Attorneys, P.A., in Lee County at 239.337.7483 or toll free at 1.888.477.4839,or by email to  Visit for more information.  You can contact Spivey Law Firm, Personal Injury Attorneys, Charlotte County at 941.764.7748 and in Collier County 239.793.7748.


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