Scrip Regulatory Affairs
07 October 2011
Vibha Sharma
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NEWS
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- US FDA says use of spilt predicates is inconsistent with 510(k) device programme
- EU Commission proposes clinical evidence requirements for all IVDs except lowest-risk
- Proposed new feature in future EU IVD Regulation: the classification rules
- GHTF consults on deleting "type examination" option from its revised conformity assessment guideline
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ANALYSIS
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EDITORIALS
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FEATURES
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COMMENT
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