Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at firstname.lastname@example.org if you need assistance.
The site navigation utilizes arrow, enter, escape, and space bar key commands. Left and right arrows move
across top level links and expand / close menus in sub levels. Up and Down arrows will open main level
menus and toggle through sub tier links. Enter and space open menus and escape closes them as well. Tab
will move on to the next part of the site rather than go through menu items.
The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.
Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.
For 20 years, our flagship publication, Fundamentals of US Regulatory Affairs, has been giving regulatory professionals the insights and answers they need, right at their fingertips.
There are hundreds of RAC testing centers available worldwide. Any of the four RAC exams (US, EU, CAN or Global) may be taken at any location. Find an upcoming exam at a location near you.
The RAPS store will be under maintenance Saturday, 28 September between 6 a.m. and 12 p.m. Store functionality may be unavailable at times during this window.
We apologize for any inconvenience caused during this time.
Posted 10 April 2012 | By Alexander Gaffney, RAC
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
Tags: Risk/Benefit, Benefit:Risk, Benefit-risk, Learn, Module, application, Latest News, De Novo, PMA, guidance, training
Regulatory Focus newsletters
All the biggest regulatory news and happenings.