Posted 10 April 2012
By Alexander Gaffney
The US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) released a new training module on a guidance document released by the agency that focuses on making benefit-risk determinations for medical device submissions.
FDA's guidance, Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications, was released 27 March 2012.
FDA noted at the time of the guidance release that it is "intended to provide greater clarity on FDA's decision making process," and to that end "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."
The three documents posted by CDRH today include a web video explaining the guidance document, a transcript of that video and all slides included in the video, all of which explain the significance of the guidance and how to best understand it.
FDA - Online Video Presentation (with Captioning)
FDA - Printable Slide Presentation
FDA - Transcript
Regulatory Focus - FDA Releases New Guidance For Industry for Benefit-Risk Evaluations in PMAs, De Novo Classifications