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.
Posted 01 November 2017 | By Zachary Brennan
Following its manufacture and distribution of adulterated automatic external defibrillators (AEDs) and Q-CPR meters, which the U.S. Food and Drug Administration (FDA) said put people at risk, US District Judge Denise Casper on Tuesday entered a consent decree of permanent injunction between the US and Andover, MA-based Philips North America LLC and two company officers.
Under a complaint filed on behalf of FDA and alongside the consent decree, Philips was said to be responsible for the manufacture and distribution of adulterated devices because its AEDs and Q-CPR Meters were made in violation of current good manufacturing practice (CGMP) requirements based on noncompliance with quality system regulations.
"AEDs are life-saving tools and are designed to be used by the general public or professionals in an emergency," Melinda Plaisier, associate commissioner for regulatory affairs at FDA, said in a statement. "People rely on these devices to work when needed. By not adequately addressing corrective and preventative actions with their AEDs in a timely manner, Philips distributed adulterated products that put people at risk."
The consent decree requires Philips' Emergency Care and Resuscitation business unit to cease operations at its Massachusetts and Bothell, WA, facilities, with certain exceptions, until it completes corrective actions, including the hiring of a qualified third-party CGMP consultant to inspect the business unit. The expert is expected to provide FDA with a report on the company's compliance, and the agency will conduct an inspection of both manufacturing facilities before Philips can resume manufacturing.
Last month, the company first announced the consent decree and said it would suspend the manufacture of some defibrillators, and back in February, the company issued a medical device correction.
The company said it would see an impact of about €80 million ($93 million) as a result of the issues in the final quarter of 2017 and all of 2018, mostly due to "the suspension of production, profit disgorgement payments, and incremental costs to prepare for and handle the regulatory inspections."
FDA
Tags: Philips, consent decree, defibrillators
Regulatory Focus newsletters
All the biggest regulatory news and happenings.