Judge Releases Device Makers From FDA Quality Policy
Posted on: Monday, 24 October 2005, 12:00 CDT
CAMP HILL, Pa., Oct. 24 /PRNewswire/ -- "Many roads lead to Rome." In those words, a Utah federal judge has released thousands of medical device companies from an FDA policy that had stipulated only one route to compliance with a nine-year-old FDA manufacturing quality regulation. That single FDA- approved route had been to satisfy the internally developed expectations of FDA officials, according to Dickinson's FDA Webview (http://www.fdaweb.com/), which has analyzed the judge's 15-page decision and placed the full text on its Web site.
Until judge Bruce S. Jenkins released a small Utah device manufacturer from the officials' detailed demands on October 21, ending a bitter four-year- old confrontation, the industry felt it had to comply with explicit quality standards approved by FDA. Now, however, they are free to deviate and use alternative practices that may not be approved by some FDA officials, the news service says.
As recently as September, FDA had argued in the Utah trial that manufacturers have a "duty" to keep up to date with its quality expectations and are not free to choose which regulations suit them best because "Congress entrusted these decisions to FDA."
Dickinson's FDA Webview is the continuously updated Internet news service on FDA health product issues that is published by Ferdic Inc., the 1982- established publisher of authoritative print and electronic newsletters on FDA-related issues.
Dickinson's FDA Webview
CONTACT: David McFarland, +1-717-731-1426, for Dickinson's FDA Webview
Web site: http://www.fdaweb.com/
Source: PRNewswire
Related Articles
- Roche and FDA Agree on Pathway Towards U.S. Approval of ACTEMRA(R) (tocilizumab)
- Cephalon Announces FDA Advisory Committee Recommendation Against Approval of an Expanded Label for FENTORA
- St. Jude Medical Announces FDA and European CE Mark Approval of the QuickFlex Family of Leads
- St. Jude Medical Announces FDA and European CE Mark Approvals of Durata Defibrillation Lead
- CORRECTING and REPLACING FDA Advisory Committee Recommends Against Approval for Merck's NDA for ARCOXIA(R) (Etoricoxib)
- FDA Puts Its Stamp of Approval on Merck's New Diabetes Drug
- St. Jude Medical Announces FDA and European CE Mark Approvals of Tendril ST(R) Pacemaker Lead
- Foley & Lardner Survey of Industry Insiders Reflects Desire for European Regulatory Approach to Follow-on Biologics; Despite Current Gridlock, 50 Percent of Respondents Believe the FDA Has the Authority to Approve Follow-on Biologics
- CORRECTED-FDA warns Wyeth on quality at Puerto Rico plant
- Laser & Varicose Vein Treatment Center Achieves National Quality Approval
 |
 |
User Comments (0)
RSS Feeds