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 raps@raps.org if you need assistance.
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 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 RAPS store will be under maintenance Saturday, 7 December between 6 AM and 12 PM. Store functionality may be unavailable at times during this window. We apologize for any inconvenience caused during this time.
Posted 20 January 2012 | By Alexander Gaffney, RAC
Consumers Union, best known for their Consumer Reports publication, is launching a campaign to persuade Congress to force manufacturers using the 510(k) medical device regulation pathway to subject their products to the same premarket safety and efficacy tests that are required of pharmaceutical products.
The 510(k) pathway is used by medical device manufacturers, and requires that manufacturers notify the US Food and Drug Administration (FDA) that they plan to market a medical device that is "substantially equivalent" to predicate devices. This pathway does not require additional safety or efficacy testing unless FDA determines that the device is not substantially equivalent.
The Consumers Union campaign seems to borrow from the Director of FDA Center for Devices and Radiological Health, Jeffery Shuren, by calling for FDA to stop the public from being "used as guinea pigs" when it comes to medical device safety and effectiveness. Shuren made remarks in early 2011 that the European Medicines Agency (EMA) was using EU citizens like "guinea pigs" by failing to subject devices to adequate testing.
Consumers Union calls for concerned citizens to contact Congress to urge them to mark up the Medical Device User Fee Act (MDUFA) to "improve the quality, safety and effectiveness" of medical devices by "demanding standards for most medical devices be brought in line with prescription drugs."
The letter goes on to demand "substantial evidence"-not "reasonable assurance"-standards be used in the approval process, improved monitoring of devices via a "unique-identifier system for implanted devices", device registries for implanted devices, retention of current conflict of interest standards and safety improvements funded through user fees.
Other information provided by Consumers Union expands upon these recommendations and demands.
Tags: Effiacy, Effectiveness, Campaign, Consumer Reports, Consumers Union, MDUFA, Latest News, Jeffery Shuren, Congress, 510(k), safety
Regulatory Focus newsletters
All the biggest regulatory news and happenings.