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 21 February 2012 | By Alexander Gaffney, RAC
The US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) has released an updated schedule describing the classification timelines of 26 device classes.
The 17 February release of the schedule is a part of CDRH's 515 Program Initiative, which is part of CDRH's overall Transparency Initiative. The 515 Program is named after Section 515 of the Federal Food, Drug and Cosmetic Act (FD&C Act) which covers the reclassification of medical devices, and seeks to provide transparency in the development of new medical device risk classifications.
As of 2009, 26 medical devices were awaiting final classification. There are currently 22 device classes in various stages of classification development. FDA has collected existing information on all 22 device classes, leaving 15 device classes at a benefit:risk assessment stage, one device class at a proposed rule stage and six device classes at in a post-proposed rule stage awaiting comment.
Tags: Program 515, Reclassification, Classification, Project 515, Transparency Initiative, Latest News, development
Regulatory Focus newsletters
All the biggest regulatory news and happenings.