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.
With so many global regulation changes, staying informed is a challenge. Join other regulatory professionals as you navigate the gray 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. Either RAC exam (Devices and Drugs) 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.
RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.
Posted 06 September 2017 | By Zachary Brennan
About a week after the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) was criticized for sending a historically low number of warning letters so far in 2017, a flood of new letters were released Wednesday.
The warning letters were sent from February through August 2017 to three manufacturers from the US, and five in Brazil, the Netherlands, Germany, China and Bulgaria.
The release of the letters follows a story in Bloomberg News highlighting that CDRH had only previously released one warning letter in 2017, which was a fraction of the number issued in previous years.
In the US, CDRH warned Boston-based SyncThink in July for marketing an eye impairment device without clearance or approval.
Henderson, Nevada-based Steiner Biotechnology also received a warning letter for not complying with federal regulations while conducting clinical studies for two products, known as Ridge Graft and Skeletal Graft.
And Plymouth, Minnesota-based Entellus Medical received a warning letter in April for deviating from clinical trial protocols in a study of a multi-sinus dilation system.
“At multiple clinical sites, Entellus Medical clinical personnel were present during procedures that included protocol deviations consisting of use of the device on the frontal and sphenoid sinuses of pediatric subjects under the age of 12,” the letter says.
CDRH also sent a warning letter to Brazil-based MB Industria Cirurgica Ltda on 4 August, with 10 observations related to the company’s failures in manufacturing wound dressings. Netherlands-based QLRAD received a warning letter in July for marketing the RectalPro Endorectal Balloon (ERB) in the US without marketing clearance or approval.
China-based Hebei Pukang Medical Instruments Co., Ltd. received a warning letter in March for its failures in manufacturing AC-powered adjustable beds, wheeled stretchers, manual beds, cabinet trays and operating room table and attachments.
Sofia, Bulgaria-based X12, meanwhile, received a warning letter sent in March for manufacturing adulterated sterile reflective marker spheres.
And Berlin-based G L E Gesellschaft für lichttechnische Erzeugnisse GmbH received a warning letter in February
SyncThink, Inc. 7/31/17
Steiner Laboratories 6/21/17
Entellus Medical 4/6/17
MB Industria Cirurgica Ltda 8/4/17
HOSPIMED 7/20/17
Hebei Pukang Medical Instruments Co., Ltd. 3/29/17
X12 Co., LTD. 3/23/17
G L E Gesellschaft Fur Lichttechnische Erzeugnisse Mbh 2/23/17
Tags: warning letters, medical device warnings
Regulatory Focus newsletters
All the biggest regulatory news and happenings.