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.
RAPS Euro Convergence brings regulatory peers from the EU and worldwide together in one forum to gain insights and exchange ideas on the region's most pressing issues. Register today to attend 10-12 May 2021.
Registration is now open for RAPS Convergence 2021! Gather with the regulatory community 12-15 September for four days of learning, engagement, and excitement.
With contributions from more than 30 authors from seven countries, the new edition incorporates a global overview of the field and is designed to help you get the most out of your regulatory intelligence endeavors.
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.
The RAPS store will be under maintenance Saturday, 17 April between 5 AM and 12 PM EST. Store functionality may be unavailable at times during this window. We apologize for any inconvenience caused during this time.
Posted 05 June 2017 | By Michael Mezher
The US Food and Drug Administration (FDA) on Friday notified medical device labelers that it is extending the compliance dates for certain unique device identifier (UDI) requirements for Class I and unclassified devices.
Rollout of FDA's UDI rule has been fraught with challenges. Since issuing the final UDI rule in 2013, FDA has pushed backcompliance dates for a number of devices in response to concerns from companies over meeting deadlines or to address specific technical challenges.
However, UDI requirements are already in effect for many higher-risk devices, including Class III, implantable and life-supporting/life-sustaining devices such as artificial heart valves and automated external defibrillators (AEDs). And, FDA says its Global UDI Database contains 1.4 million records submitted by more than 4,000 device labelers.
FDA says it is extending the requirements for Class I and unclassified devices to bear a UDI on their labels and packages, as well as the requirement for those devices to submit data to GUDID, from 24 September 2018 to 24 September 2020.
The agency is also delaying the direct mark requirement for Class I and unclassified devices, which requires devices to bear a UDI on the device itself if the device is reusable and must be reprocessed before each use, from 24 September 2020 to 24 September 2022.
FDA says it is delaying the requirements in order to work out some of the challenges related to UDI for higher-risk devices before the influx of lower-risk devices enter the system, and in response to concerns from industry about meeting the compliance dates.
"We identified complex policy and technical issues that need resolution, such as how UDI applies to products such as medical procedure trays that contain implantable devices and instruments. Providing accurate and timely support to labelers has also been challenging, due to the sheer number and wide diversity of devices," FDA writes.
Going forward, FDA says it is planning to issue a guidance document to detail its enforcement discretion policy for labeling, GUDID data submission, standard date formatting and direct mark requirements for the affected devices.
FDA
Tags: Unique Device Identifier, UDI
Regulatory Focus newsletters
All the biggest regulatory news and happenings.