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 14 July 2015 | By Michael Mezher
The US Food and Drug Administration (FDA) is seeking input as it begins to draft a new guidance intended to help makers of magnetic resonance diagnostic devices (MRDDs) complete premarket notification 510(k) applications.
After scientific advances in the 1970s led to the first images produced using magnetic resonance (MR), clinical interest in the technology grew rapidly. In the 1980s, these advances made magnetic resonance imaging (MRI) useful for clinical applications, especially for cardiac imaging.
Now MR technology is commonly used for imaging many parts of the body, including the head and brain, blood vessels, abdomen, pelvic region and spine.
As a new technology, MRDDs were considered to be Class III devices, which required premarket approval (PMA) and the completion of a premarket notification 510(k) before they could be marketed.
However, by 1988, FDA felt sufficient evidence had been gathered demonstrating the safety of MRDDs, and reclassified them to the lower-risk Class II.
Unlike other imaging techniques such as X-rays or CT scans, MRDDs do not emit harmful radiation. However, there are still risks due to the strong magnetic field generated by these devices. As such, MRDDs should not be used with certain implantable medical devices.
FDA's current Guidance for the Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices was introduced in 1998.
Since then, there have been numerous technological and scientific developments that have improved MR technology, including the advent of magnetic resonance spectroscopy and functional MRI (fMRI).
FDA says the new guidance will help clarify the formatting and information the agency expects for 510(k) premarket notification for MRDDs. The new guidance will also apply to "new magnetic resonance imaging (MRI) and magnetic resonance spectroscopy systems, new components, and modifications to systems and components that have a significant impact on safety or effectiveness of the [MRDD]."
FDA is asking interested parties to submit their comments on the draft guidance before 13 October 2015 to be considered before the agency begins work on the final guidance.
Federal Register, Draft Guidance
Tags: Magnetic resonance diagnostic device, Magnetic resonance imaging, MRDD, MRI, 510(k)
Regulatory Focus newsletters
All the biggest regulatory news and happenings.