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.
RAPS Convergence is going virtual. Join the brightest minds in regulatory online to gain the latest knowledge in the field in an all-virtual experience with workshops, one-on-one expert sessions, and networking communities.
Euro Convergence 2020 is moving towards a rewarding week. We are now offering an enhanced hybrid format with both in-person and online sessions from Monday 26 to Friday 30 October 2020.
Learn how recent changes to the regulation of healthcare products in the EU will impact you as a regulatory professional.
In light of the COVID-19 pandemic, the RAC Board has elected to offer online testing with live online proctoring this summer.
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 Learning Portal will be under maintenance Saturday, 8 August between 6 AM and 6 PM EST. Portal functionality will be unavailable during this window. We apologize for any inconvenience caused during this time.
RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.
Posted 14 May 2014 | By Alexander Gaffney, RAC,
The Center for Devices and Radiological Health (CDRH), the US Food and Drug Administration's (FDA) device regulatory body, has released another update-its 35th-to its list of recognized third-party standards.
Standards for the proper manufacture and testing of products are often highly technical, time-consuming to produce and, above all else, expensive to create. Rather than create its own standards or duplicate the efforts of other groups, FDA often chooses to adopt the standards of outside groups wholesale or with minor alterations.
The process, known as Incorporation by Reference, involves FDA formally recognizing those standards in the Federal Register, which it typically does several times each year. Sponsors of device applications can use those standards in several ways, which are outlined in the guidance document Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices.
On 14 May 2014, FDA released its 35th update to its list of recognized standards.
Unlike its 34rd update, which listed hundreds of changes and nearly two dozen additions, FDA's latest changes impact just three radiology standards:
All three will again be recognized by FDA, the agency said.
All standards are available through FDA's searchable database, located at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm .
Federal Register Notice
Tags: Radiology, Consensus Standards, IEC, Latest News
Regulatory Focus newsletters
All the biggest regulatory news and happenings.