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 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.
Share your knowledge and expertise with your regulatory peers by submitting an in-depth, evidence-based article focusing on key areas and emerging issues in the global regulatory landscape.
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.
Registration is now open for RAPS Convergence 2021! Gather with the regulatory community 12-15 September for four days of learning, engagement, and excitement.
Keep the sparks coming! Delegates of the conference have access to on-demand content until the end of October 2021.
This updated edition is a great reference for anyone working in multinational product development and marketing.
Regipedia is an interactive resource created to benefit RAPS members with 24/7 access to more than 2,300 regulatory terms.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
Posted 09 July 2014 | By Alexander Gaffney, RAC,
US medical device regulators have announced more than 30 new additions to their list of recognized device consensus standards.
In a Federal Register announcement on 9 July 2014, the US Food and Drug Administration (FDA) announced its 36th update to its "List of Recognized Standards"—its fourth update to the list in 2014—containing dozens of modifications and 33 newly recognized standards.
Those standards come to be recognized by FDA through a process known as "incorporation by reference." Because the standards are often highly technical, time-consuming to produce and expensive to create, FDA defers to outside technical experts to create the standards, and then adopts those standards—sometimes with changes, but most often without—for use by regulated industry.
Members of industry are then responsible for complying with those standards, and usually must pay to access them.
So far this year, FDA has released three updates to the list of recognized standards:
Those updates have ranged from the minute, such as update 33's five new standards and 35's three new standards, but can also be massive, such as update 34's hundreds of changes and two dozen additions.
FDA's newest Recognition List, number 36, appears to be its largest yet this year, with 33 new standards and 153 changes to existing standards.
All newly-recognized standards may be found below. All other standards can be found in FDA's Federal Register notice.
Tags: List of Recognized Standards, Medical Device Standards, Incorporation by Reference
Regulatory Focus newsletters
All the biggest regulatory news and happenings.