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 02 May 2012 | By Alexander Gaffney, RAC
A decision by the US Centers for Medicare & Medicaid Services (CMS) to cover transcatheter aortic valve replacement (TAVR) procedures for patients enrolled in Medicare is among the first under an October 2011 memorandum of understanding with the US Food and Drug Administration (FDA).
"This decision is particularly important as it highlights cooperative efforts among CMS, FDA, the Agency for Healthcare Research and Quality, medical specialty societies and the medical device industry," wrote CMS Acting Administration Marilyn Tavenner.
TAVR, used to treat patients with a damaged aortic heart valve, is being hailed by CMS as a minimally-invasive procedure that will benefit patients who are unable to undergo open heart surgery.
Under CMS's decision, any TAVR devices that receive pre-market approval from FDA and meet additional treatment criteria will be eligible for reimbursement.
Read more:
CMS - CMS to cover new technology for Medicare patients with heart valve damage
CMS - National Coverage Analysis (NCA) for Transcatheter Aortic Valve Replacement (TAVR) (CAG-00430N)
CMS - Decision Summary
CardioSource - CMS Releases Official National Coverage Determination of TAVR
Forbes - CMS Issues National Coverage Decision for TAVR
Med Page Today - Medicare to Pay for TAVI
Modern Healthcare - Medicare to cover heart-valve procedure
FDA - FDA, CMS launch pilot program for voluntary parallel review of innovative devices
Tags: National Coverage Analysis, NCA, Edwards, Tavenner, TAVR, Medicare, Latest News, CMS, medical device
Regulatory Focus newsletters
All the biggest regulatory news and happenings.