Regulatory Focus™ > News Articles > FDA Releases New Guidance For Industry for Benefit-Risk Evaluations in PMAs, De Novo Classifications

FDA Releases New Guidance For Industry for Benefit-Risk Evaluations in PMAs, De Novo Classifications

Posted 27 March 2012 | By Alexander Gaffney, RAC 

The US Food and Drug Administration (FDA) released new guidance on 27 March for benefit-risk determinations in premarket approvals (PMAs) and de novo classifications for medical devices.

The guidance, Factors to Consider when Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications, "is intended to provide greater clarity on FDA's decision making process," FDA wrote.

According to the guidance document, "this guidance sets out the principal factors FDA considers when making this determination and explains them in detail [and] also gives examples of how the factors interrelate and how they may affect FDA's decisions."

Regulatory professionals may find the guidance to be a useful look into how FDA conducts benefit-risk evaluations. Attached to the guidance via an appendix are two worksheets that FDA uses to maintain review consistency when evaluating a medical device's benefits and risks.


Read more:

Federal Register - Guidance for Industry and Staff; Availability: Factors to Consider when Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications


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