Please login to read the full article.
Scrip Regulatory Affairs
Industry expresses concern over US FDA guideline on device changes needing new 510(k)s
26 October 2011
Vibha Sharma
Please login to read the full article.
Not a subscriber ? Request a FREE Trial
Subscribe to Regulatory Affairs Pharma
RELATED CONTENT
NEWS
Scrip Regulatory Affairs News
- US FDA clarifies which device modifications will need a new 510(k) submission
- US FDA says use of spilt predicates is inconsistent with 510(k) device programme
- US FDA proposes revised criteria for accepting only "complete" device submissions
- US FDA device reviewers to use new worksheet from 1 May to capture benefit-risk determinations
Other Informa News
ANALYSIS
Regulatory Affairs Pharma Analysis
Other Informa Analysis
EDITORIALS
Regulatory Affairs Pharma Editorials
Other Informa Editorials
FEATURES
Regulatory Affairs Pharma Features
Other Informa Features
COMMENT
Regulatory Affairs Pharma Comment
Other Informa Comments
