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Regulatory & Policy

News COMMISSION RECOMMENDATION
01 Sep 2013
News US FDA Updates Plans for UDI and Post-Market Surveillance System
05 Apr 2013
News IMDRF Recommendations for UDI Systems
01 Apr 2013
News Europe's Proposed Medical Device Regulation
01 Mar 2013
News eIFU from 1st March 2-13 - European Commission Regulation (EU) No 207/2012
01 Feb 2013
News Scientific Disagreements Regarding Medical Device Regulatory Decisions
01 Jun 2012
News Factors to consider when making benefit-risks determinations in Medical Device Pre-market approval and De Novo classifications
01 Mar 2012
News New Borderline & Classification Medical Device document
09 Apr 2012
News MEDDEV 2.1/3 Rev3
08 Apr 2012
News MEDDEV 2.12-1 Rev6
07 Apr 2012
News Medical Device Directive
06 Apr 2012
News Medical Device Directive
05 Apr 2012
News Medical Device Directive
05 Apr 2012
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Factors to consider when making benefit-risks determinations in Medical Device Pre-market approval and De Novo classifications 01 Mar 2012

FDA has developed this guidance document to provide greater clarity for FDA reviewers and industry regarding the principal factors FDA considers when making benefit-risk determinations during the premarket review process for certain medical devices. FDA believes that the uniform application of the factors listed in this guidance document will improve the predictability, consistency, and transparency of the premarket review process.

FDA's guidance documents, including this one, do not establish legally enforceable responsibilities. Instead, guidance documents describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidance documents means that something is suggested or recommended, but not required.

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