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.
Posted 15 May 2014 | By Alexander Gaffney, RAC,
The US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) has proposed that two medical devices marketed prior to the 1976 Medical Device Amendments to the Federal Food, Drug and Cosmetic Act (FD&C Act) be subject to less stringent regulation.
In two separate Federal Register announcements, FDA said it would permit intravascular administration sets and colon capsule imaging systems, respectively, to be classified as Class II devices under the FD&C Act.
The devices, having been approved prior to the Medical Device Amendments, had been classified as Class III—high risk—devices subject to premarket approval (PMA) requirements.
Under the new classifications, they will be subject to premarket notification requirements [510(k)] along with general controls and special controls meant to ensure that they are safe and effective, but without the need to conduct extensive clinical trials.
Both orders will be made final 30 days after 16 May 2014.
Medical Devices: Classification of the Colon Capsule Imaging System
Medical Devices: Classification of the Intravascular Administration Set, Automated Air Removal System
Tags: CDRH, Medical Device, Device Reclassification, Final Rule, Class II, Down-classification
Regulatory Focus newsletters
All the biggest regulatory news and happenings.