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 13 January 2014 | By Alexander Gaffney, RAC,
The Center for Devices and Radiological Health (CDRH), the US Food and Drug Administration's (FDA) medical device regulator, has announced that it plans to recognize five new standards maintained by outside groups and intended for medical electrical equipment.
Standards for the proper manufacture of products are often highly technical, time-consuming to produce and, above all else, expensive to create. Rather than create its own standards or duplicate the efforts of other groups, FDA often chooses to adopt the standards of outside groups wholesale or with minor alterations.
The process, known as Incorporation by Reference, involves FDA formally recognizing those standards in the Federal Register, which it does several times each year.
The latest set of references listed in the Federal Register by FDA includes a list of 41 standards that are set to be retired, generally because they were succeeded by newer versions of the same standard.
But in addition to the 41 outgoing standards, FDA's Federal Register announcement also includes five new medical electrical equipment standards set to be recognized by FDA as being appropriate for use in their respective settings:
Recognition No.
Title of Standard
Reference Number and Date
5-78
Medical electrical equipment--Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD)
ANSI/AAMI ES60601-
1:2005/(R)2012 and
C1:2009/(R)2012 and
A2:2010/(R)2012
(Consolidated Text)
12-257
Medical electrical equipment--Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography
IEC 60601-2-44 Edition
3.0 2009-02
12-268
Medical electrical equipment--Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
IEC 60601-2-22 Edition
3.1 2012-10
12-269
Medical electrical equipment--Part 1-3: General requirements for basic safety and essential performance--Collateral standard: radiation protection in diagnostic X-ray equipment
IEC 60601-1-3 Edition 2.1
2013-04
12-271
Medical electrical equipment--Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis
IEC 60601-2-33 Edition
3.1 2013-04
A full list of all recognized standards maintained by FDA may be found on its website, here.
Federal Register notice
Regulatory Focus newsletters
All the biggest regulatory news and happenings.