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 12 December 2017 | By Zachary Brennan
The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) on Tuesday issued its first report on patient-reported outcomes (PROs), noting a significant uptick in PRO data submitted in 2017.
Over a six-year period, the report says CDRH observed a more than 500% increase in the number of pre-market submissions that include PRO measures.
And in FY 2017, more than 75% of approved, pivotal original and new study investigational device exemptions (IDEs) submitted to the Office of Device Evaluation (ODE) included a PRO measure within the submission.
"The significant increase in the number of product applications submitted with patient perspective information shows that manufacturers, like the FDA, recognize the value of this information," CDRH Director Jeff Shuren said in a statement.
But the use of PROs in post-approval studies (PAS) has fluctuated, from six of 19 (32%) studies including a PRO in 2015, to four of 16 (25%) including a PRO in 2016 to three in 10 (30%) studies including a PRO in 2017, the report finds.
"Assessing trends on the use of PROs in postmarket mandated studies is challenging because the numbers are driven by the questions that need to be addressed," the report says.
The report also features examples of using PROs as patient priority measures, in clinical care, as safety endpoints and as a customizable measure specific to a treatment area and/or specific device.
Moving forward, CDRH says it will develop a "fit-for-purpose" framework for assessing validation evidence for PROs and a template for sponsors choosing to perform a bridging study to develop or modify a PRO to facilitate their conduct and reporting of a study.
Value and Use of Patient-Reported Outcomes (PROs) in Assessing Effects of Medical Devices
Tags: patient-reported outcomes, medical device submissions
Regulatory Focus newsletters
All the biggest regulatory news and happenings.