Most Popular Stories
- Case study: NYC works to manage diabetes
- Verizon is the latest telecom to seek riches in mobile healthcare
- Medical liability premiums dropping nationwide
- Initial 'meaningful use' standards to be simple, as deadline is in sight
- Doctors win 4th delay of FTC "red flag" rules
- Open-source EMR opens doors to quality care
Featured Jobs
-
Hospitalist Job for Georgia
StaffPointe, LLC - south, GA -
Urologist Job in Pennsylvania
StaffPointe, LLC - south of Erie, PA -
Hospitalist Job in Indiana
StaffPointe, LLC - south, IN -
Family Practice Job in Indiana
StaffPointe, LLC - Indianapolis, IN -
Emergency Department Clinical Mgr Job in MD
StaffPointe, LLC - Baltimore, MD
Events
- Harvard Business School 7th Healthcare Conference
January 30, 2010 - Security Audits: Is Your Organization Prepared and In Compliance?
Dec.3 at 12 pm CT
Paid Research Reports
- Pricing and Reimbursement in Key Asia Pacific Markets
- Delivery Mechanisms for Large Molecule Drugs: Successes and failures of leading technologies and key drivers for market success
- The Cardiovascular Market Outlook to 2013: Competitive landscape, global market analysis and pipeline analysis
- Intellectual Property and Outsourcing in China: Minimizing risk whilst maximizing return on investment
- Health Care Equipment & Supplies: Global Industry Guide
- 2009 Trends to Watch: Healthcare Technology
FEATURES >> YouTube | Top acute-care hospitals | Women in Health IT | Top BlackBerry Apps | Commentary
TOPICS >> Stimulus | Health Reform | CMS News | Finance | EMRs | Mobile Healthcare | Hospital Leadership Blog
Free Newsletter
FierceHealthcare is the leading source of healthcare management news for healthcare industry executives. Join 46,000+ healthcare industry insiders who get FierceHealthcare via daily email. Sign up today!
Popular Topics
- Medicare
- health plans
- Centers for Medicare and Medicaid Services (CMS)
- Insurance
- Electronic Medical Records (EMRs)
- Food and Drug Administration (FDA)
- Department of Health and Human Services (HHS)
- Medicaid
- American Medical Association (AMA)
- healthcare system
- health reform
- prescription drugs
- pharmaceutical companies
Federal regulators to check safety levels of 'legacy devices'
In a move that seems like it's been decades in the making, federal regulators announced that they would be checking the safety levels of risky medical devices. The move was spurred by a report issued in January by the Government Accountability Office that came down hard on the FDA's system of reviewing legacy devices--medical devices created before 1976.
The legacy devices initially were allowed to hit the market without much testing. Congress stepped in, in 1976, ordering the FDA to reclassify older devices to determine which ones needed more testing before approval of new versions. It was a process the FDA failed to complete, and resulted in products such as external defibrillators and pacemaker components going untested; 27 devices in all went unexamined.
According to FDA spokeswoman Mary Long, there is no timetable for the project's completion. "We have to review each device type separately," she said. "It will take some time."
For more on this issue:
- check out this New York Times article
Related Articles:
FDA investigated for improper review of medical devices
FDA to tighten medical device safety regs
FDA's medical approval process faces GAO scrutiny
Related Stories
- ALSO NOTED: FDA to require device IDs; Pay for performance takes root in Philly; and much more...
- Decision makes it harder to sue device makers
- SPOTLIGHT: To cut costs, more hospitals re-using devices
- FDA's medical approval process faces GAO scrutiny
- FDA device chief quits; Wireless home health exploding;
- Group says YouTube medical device ads may be illegal
- FDA investigated for improper review of medical devices
- FDA says CT scans can make medical devices malfunction
- CMS makes Part D data available for patient-safety efforts
- Groups ask FDA to push for unique medical device IDs
Comments
Post new comment
Home
| Subscribe | Advertise | Mobile Edition | RSS |
Privacy
| Site Map | List in Marketplace | Supplier MarketplaceTHE FIERCEMARKETS NETWORKFierceFinance | FierceFinanceIT | FierceComplianceIT | FierceHealthcare | FierceHealthFinance | FierceHealthIT | Hospital Impact | FierceMobileHealthcare | FierceCIO | FierceCIO:TechWatch | FierceContentManagement | FierceMobileIT | FierceGovernmentIT | FierceBiotech | FierceBiotech Research | FiercePharma | FierceVaccines | FierceBiotechIT | FiercePharma Manufacturing | FierceIPTV | FierceOnlineVideo | FierceTelecom | FierceVoIP | FierceBroadbandWireless | FierceDeveloper | FierceMobileContent | FierceWireless | FierceWireless:Europe© 2009 FierceMarkets, Inc. All rights reserved. |
![]() |





