Medical device changes to come in U.S.
Last Updated: Thursday, January 20, 2011 | 10:01 AM ET
The Associated Press
The U.S. Food and Drug Administration is laying out plans to update the 35-year-old system used to approve most medical devices, which has been subject to increasing criticism by public safety advocates.
The agency announced a series of changes it plans to make this year, including streamlining the review process for some low-risk devices. But regulators said they will delay a decision on the most drastic proposals, which would give the government new power to police device makers.
Those proposals, widely supported by public safety advocates, included clarifying the FDA's power to revoke approval for products that prove unsafe or ineffective. Another key proposal would have established a new subset of devices that would require more medical data to gain approval.
But those proposals, unveiled for comment last summer, received strong pushback from device companies, and the FDA said in its report "that implementing them may be problematic."
The device industry's chief trade group, AdvaMed, lobbied against the changes, saying they would make device reviews longer and more expensive, hurting innovation and endangering jobs. The group represents most of the largest device firms, including Medtronic Inc., Stryker Corp. and Johnson & Johnson.
AdvaMed president Stephen Ubl called Wednesday's announcement "a good first step that will address some of the major problems with the program."
'Lobbyists won'
But Dr. Diana Zuckerman of the National Research Center for Women and Families said the FDA's plan suggests "industry lobbyists won, and the public lost."
"Today's FDA report gives the impression that FDA backed down on several safeguards as a result of unfavorable comments," Zuckerman said in a statement. "FDA decisions should not be based on a popularity contest, especially since lobbyists rig the results."
The FDA said it would wait for the guidance of the Institute of Medicine before making a final decision on more sweeping changes.
The group, which advises the federal government on medical issues, is expected to make its recommendations this summer.
The so-called 510(k) system for devices was created in 1976 to grant speedy approval to devices that are similar to products already on the market. It is popular among manufacturers because it is a faster, cheaper path to market than the review process for novel devices, which must undergo rigorous medical testing.
Hip replacements and drug pumps are among the devices cleared under the system.
But FDA critics say that high-risk devices, such as heart pacemakers, are increasingly slipping through the 510(k) process without thorough testing and scrutiny.
About 4,000 devices are cleared every year under the 510(k) system, while about 50 devices are approved under the more stringent system.
Share Tools
Top News Headlines
- Ottawa won't appeal veterans' court victory on pensions
- The federal government will not appeal a Federal Court of Canada ruling that rejected clawbacks from the pensions of disabled veterans. more »
- New Italian earthquake death toll rises to 15
- A magnitude 5.8 earthquake hit northern Italy on Tuesday, killing at least 15 people in the same region still struggling to recover from another fatal tremor on May 20. more »
- Robocalls may need regulating, elections chief tells MPs
- Elections Canada may recommend the government regulate contact with voters during election campaigns, Chief Electoral Officer Marc Mayrand told MPs today, after loggging 1,100 complaints over robocalls from the last election. more »
- Canadian climber's body taken off Everest
- The body of a Toronto woman who died while descending from the summit of Mount Everest earlier this month has been taken by helicopter to her family in the Nepalese capital of Kathmandu. more »
Latest Health News Headlines
- Transplanting lungs from smokers worthwhile
- Lung transplant patients who receive the organs from smokers have better chances of survival than those who stay on waiting lists, a British study suggests. more »
- Baby boomers' health demands will pose challenges
- With the largest generation ever starting to crest the hill of old age, medical specialties that deal with older adults are getting ready for the inevitable onslaught. more »
- Oka drowning deaths preventable, expert says
- Nearly 500 people attend the funeral for one of two young men who drowned over the weekend at Oka beach — a tragedy a lifesaving specialist says could have been prevented. more »
- Displaced methadone patients find new providers
- Patients who were left in the lurch when a St. John's pharmacy abruptly closed this month are finding new supplies of medically-prescribed methadone, officials say. more »
FEATURED HEALTH
- 'Engine shutdown' forced Air Canada jet to land
- Richard Branson suggests naked kitesurfing to premier
- Evolution skeptics will soon be silenced by science: Richard Leakey
- Newly discovered malware most lethal cyberweapon to date
- Tornado could touch down in eastern Ontario
- Canada has higher proportion of seniors than ever before
- New Italian earthquake death toll rises to 15
- Canadian climber's body taken off Everest
- RCMP commissioner pledges to rid force of 'bad apples'

