Featured Research

from universities, journals, and other organizations

Most medical devices recalled because of serious risks did not undergo clinical trials

Date:
February 28, 2011
Source:
JAMA and Archives Journals
Summary:
Most medical devices recently recalled by the Food and Drug Administration because of very serious risks were initially approved through an expedited process or were exempt from regulatory review, according to a new article.

Most medical devices recently recalled by the Food and Drug Administration because of very serious risks were initially approved through an expedited process or were exempt from regulatory review, according to a report posted online February 14 that will be published in the June 14 print issue of Archives of Internal Medicine.

"Unlike prescription drugs, medical devices are reviewed by the U.S. Food and Drug Administration (FDA) using two alternative regulatory standards:

(1) premarket approval, which requires clinical testing and inspections; or

(2) the 510(k) process, which requires that the device be similar to a device already marketed (predicate device)," the authors write.

"The second standard is intended for devices that the FDA deems to involve low or moderate risk."

Diana M. Zuckerman, Ph.D., of the National Research Center for Women & Families, Washington, D.C., and colleagues analyzed the FDA's list of high-risk device recalls from 2005 to 2009. Using FDA data, the authors determined whether recalled devices were approved by the more rigorous premarket approval process, the less stringent 510(k) process or were exempt from FDA review.

Between 2005 and 2009, 113 devices were recalled because the FDA determined those devices could cause serious health problems or death. Of these, 21 (19 percent) had been approved through the premarket approval process, 80 (71 percent) were approved through the 510(k) process and eight (7 percent) were exempt from regulation. "Of the recalled devices cleared for market through the 510(k) process, 12 percent were marketed for risky or life-sustaining Class III indications, which are required by law to undergo a full premarket approval regulatory review," the authors write.

The high-risk recalls included devices with a broad range of clinical applications, but the most common were cardiovascular devices (31 percent). Of these, two-thirds (23, or 66 percent) were approved using the expedited 510(k) process and 12 (34 percent) were cleared through the postmarket approval process.

"The FDA's implementation of the 510(k) process has received considerable criticism from public health advocates and from other federal agencies in reports, medical journal articles and testimony before Congress," the authors write. U.S. courts have also recognized the shortcomings of the expedited process. However, the relatively small division of the FDA charged with device approvals does not receive sufficient funding from Congress to conduct premarket approval on every device, the authors note.

"When devices that were intentionally exempt from any FDA review were added to the 510(k) devices, they comprise more than three out of four of the high-risk recalls during the last five years," they conclude. "Thus, the standards used to determine whether a medical device is a high-risk or life-sustaining medical product prior to approval are clearly very different from the standards used to recall a medical device as life threatening. Our findings reveal critical flaws in the current FDA device review system and its implementation that will require either congressional action or major changes in regulatory policy."


Story Source:

The above story is based on materials provided by JAMA and Archives Journals. Note: Materials may be edited for content and length.


Journal Reference:

  1. Diana M. Zuckerman, Paul Brown, Steven E. Nissen. Medical Device Recalls and the FDA Approval Process. Arch Intern Med., February 14, 2011 DOI: 10.1001/archinternmed.2011.30

Cite This Page:

JAMA and Archives Journals. "Most medical devices recalled because of serious risks did not undergo clinical trials." ScienceDaily. ScienceDaily, 28 February 2011. <www.sciencedaily.com/releases/2011/02/110214162926.htm>.
JAMA and Archives Journals. (2011, February 28). Most medical devices recalled because of serious risks did not undergo clinical trials. ScienceDaily. Retrieved April 16, 2014 from www.sciencedaily.com/releases/2011/02/110214162926.htm
JAMA and Archives Journals. "Most medical devices recalled because of serious risks did not undergo clinical trials." ScienceDaily. www.sciencedaily.com/releases/2011/02/110214162926.htm (accessed April 16, 2014).

Share This



More Health & Medicine News

Wednesday, April 16, 2014

Featured Research

from universities, journals, and other organizations


Featured Videos

from AP, Reuters, AFP, and other news services

Could Even Casual Marijuana Use Alter Your Brain?

Could Even Casual Marijuana Use Alter Your Brain?

Newsy (Apr. 16, 2014) A new study conducted by researchers at Northwestern and Harvard suggests even casual marijuana use can alter your brain. Video provided by Newsy
Powered by NewsLook.com
Ebola Outbreak Now Linked To 121 Deaths

Ebola Outbreak Now Linked To 121 Deaths

Newsy (Apr. 15, 2014) The ebola virus outbreak in West Africa is now linked to 121 deaths. Health officials fear the virus will continue to spread in urban areas. Video provided by Newsy
Powered by NewsLook.com
Cognitive Function: Is It All Downhill From Age 24?

Cognitive Function: Is It All Downhill From Age 24?

Newsy (Apr. 15, 2014) A new study out of Canada says cognitive motor performance begins deteriorating around age 24. Video provided by Newsy
Powered by NewsLook.com
How Mt. Everest Helped Scientists Research Diabetes

How Mt. Everest Helped Scientists Research Diabetes

Newsy (Apr. 15, 2014) British researchers were able to use Mount Everest's low altitudes to study insulin resistance. They hope to find ways to treat diabetes. Video provided by Newsy
Powered by NewsLook.com

Search ScienceDaily

Number of stories in archives: 140,361

Find with keyword(s):
Enter a keyword or phrase to search ScienceDaily for related topics and research stories.

Save/Print:
Share:

Breaking News:
from the past week

In Other News

... from NewsDaily.com

Science News

Health News

Environment News

Technology News



Save/Print:
Share:

Free Subscriptions


Get the latest science news with ScienceDaily's free email newsletters, updated daily and weekly. Or view hourly updated newsfeeds in your RSS reader:

Get Social & Mobile


Keep up to date with the latest news from ScienceDaily via social networks and mobile apps:

Have Feedback?


Tell us what you think of ScienceDaily -- we welcome both positive and negative comments. Have any problems using the site? Questions?
Mobile: iPhone Android Web
Follow: Facebook Twitter Google+
Subscribe: RSS Feeds Email Newsletters
Latest Headlines Health & Medicine Mind & Brain Space & Time Matter & Energy Computers & Math Plants & Animals Earth & Climate Fossils & Ruins