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 July 30, 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 July 30, 2014).

Share This




More Health & Medicine News

Wednesday, July 30, 2014

Featured Research

from universities, journals, and other organizations


Featured Videos

from AP, Reuters, AFP, and other news services

Health Insurers' Profits Slide

Health Insurers' Profits Slide

Reuters - Business Video Online (July 30, 2014) Obamacare-related costs were said to be behind the profit plunge at Wellpoint and Humana, but Wellpoint sees the new exchanges boosting its earnings for the full year. Fred Katayama reports. Video provided by Reuters
Powered by NewsLook.com
Concern Grows Over Worsening Ebola Crisis

Concern Grows Over Worsening Ebola Crisis

AFP (July 30, 2014) Pan-African airline ASKY has suspended all flights to and from the capitals of Liberia and Sierra Leone amid the worsening Ebola health crisis, which has so far caused 672 deaths in Guinea, Liberia and Sierra Leone. Duration: 00:43 Video provided by AFP
Powered by NewsLook.com
At Least 20 Chikungunya Cases in New Jersey

At Least 20 Chikungunya Cases in New Jersey

AP (July 30, 2014) At least 20 New Jersey residents have tested positive for chikungunya, a mosquito-borne virus that has spread through the Caribbean. (July 30) Video provided by AP
Powered by NewsLook.com
Generics Eat Into Pfizer's Sales

Generics Eat Into Pfizer's Sales

Reuters - Business Video Online (July 29, 2014) Pfizer, the world's largest drug maker, cut full-year revenue forecasts because generics could cut into sales of its anti-arthritis drug, Celebrex. Fred Katayama reports. Video provided by Reuters
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