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.
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.
Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.
For 20 years, our flagship publication, Fundamentals of US Regulatory Affairs, has been giving regulatory professionals the insights and answers they need, right at their fingertips.
There are hundreds of RAC testing centers available worldwide. Any of the four RAC exams (US, EU, CAN or Global) may be taken at any location. Find an upcoming exam at a location near you.
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 13 February 2018 | By Zachary Brennan
Device companies Johnson & Johnson, Abbott and industry group AdvaMed offered their opinions on which guidance documents they believe the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) should prioritize this year, according to comments posted Monday to the docket.
The comments follow CDRH’s offering up a list of prioritized draft and final medical device guidance documents (known as the "A" list) and others CDRH intends to publish (known as the "B" list).
Of the final guidance documents on the "A" list, AdvaMed said the ones that are of the highest priority to its member device companies are related to the appropriate use of voluntary consensus standards in premarket submissions (draft issued in 2014 and also mentioned by Abbott and the Medical Imaging & Technology Alliance as a priority), one on next generation sequencing-based in vitro diagnostics (IVDs) and one on the use of public human genetic variant databases to support clinical validity for genetic- and genomic-based IVDs.
Highest priority draft guidance on the "A" list, according to AdvaMed, include those related to the 510(k) third party review program, expansion of the abbreviated 510(k) program with demonstrations of substantial equivalence (also mentioned as a priority for Abbott), the application of acceptable uncertainty to support marketing authorization decisions, and the validation of automated process equipment software (also noted by Abbott).
AdvaMed also made recommendations on FDA finalizing several of the draft guidances issued within the last year, moving certain guidance documents from the "A" to the "B" list, and which other guidances should be updated and revised.
J&J, meanwhile, requested that FDA include "Unique Device Identification System: Defining the Labeler Guidance for Industry and Food and Drug Administration Staff" as a draft guidance in the priorities list.
"We believe this guidance should be added to the Priority ‘A’ Draft-list to ensure that the term of UDI Labeler is created and defined to ensure the proper party is submitting Global Unique Device Identification Database (GUDID) data as this supports FDA focus on GUDID data quality," J&J said, also requesting the finalization of the draft guidance on UDI form and content from July 2016 and its inclusion in the "A" list.
Another request for the "A" list of draft guidance from J&J is one on patient-specific orthopedic implants created from patient imaging scans with the use of segmentation and planning software.
In addition, Abbott said it prioritized draft guidance on export certificates and considerations for multifunctional devices.
Comments
Regulatory Focus newsletters
All the biggest regulatory news and happenings.