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.
Resources, news and special offers to support you and your professional development during this difficult time.
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.
Download your copy of the new events calendar and see all the online workshops, conferences, RAC exams and European online workshops RAPS has planned for 2021 at a glance.
Registration is now open for RAPS Euro Convergence 2021! Attend to join peers from EU and around the world to gain insights and exchange ideas on the regions most pressing issues.
An invaluable resource for any professional engaged in designing, composing, compiling, or commenting on regulatory documentation
From self-assessments to help you identify your strengths and areas to focus on to reference books and online courses that will help you fill in the gaps in your regulatory knowledge, RAPS has the resources to help you prepare for the RAC exam.
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 16 December 2013 | By Alexander Gaffney, RAC,
The US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) has unveiled new improvements to its medical device recalls database, allowing members of industry and the public to more easily associate devices and safety recall issues.
Prior to the new database, searches for a device yielded separate results for its labeling/approval information and any recalls. This could be problematic for healthcare providers, who would have no way of knowing if an approved device was associated with any issues, and industry, which might be developing a similar device to an approved predicate but be unaware of prior issues.
The new system will join FDA's Medical Device Recalls Database and its 510(k) premarket notification and premarket approval (PMA) databases.
The benefit, FDA explained, will be that the 510(k) and PMA databases will have embedded hyperlinks that lead directly to any information on recalls associated with a particular medical device.
In addition, the recalls database has also seen a major upgrade, FDA explained.
"The recalls database has been expanded to include recall status (whether or not the recall has been terminated), product classification (product code), premarket submission numbers associated with the recall (510(k)s and PMAs only), and the root cause of the recall as determined by the FDA."
Further, a new search option will link up the recalls database with FDA's Total Product Lifecycle (TPLC) database to find other products with the same PMA or 510(k) product code. Similar products often exhibit similar physical defects or safety issues.
Search terms have also been changed slightly, with FDA modifying the "reason for recall" field to now read, "manufacturer reason for recall." FDA said the wording change better reflects the "source of the information," and that it is not necessarily FDA's determination.
Also, the previously available field "Reason for Recall" has been renamed "Manufacturer Reason for Recall" to better clarify the source of the information, FDA said.
FDA Statement
Tags: Recall, 510(k), PMA, medical device
Regulatory Focus newsletters
All the biggest regulatory news and happenings.