RAPS is the largest global organization of and for those involved with the regulation of healthcare and related products, including medical devices, pharmaceuticals, biologics and nutritional products. Founded in 1976, RAPS helped establish the regulatory profession and continues to actively support the professional and lead the profession as a neutral, non-lobbying nonprofit organization.

Stay informed on the latest healthcare regulatory news through RAPS’ online magazine, Regulatory Focus and its companion daily e-newsletter RF Today, or by following RAPS on social media, including TwitterLinkedIn and Facebook.

Reporters, bloggers and other members of the media interested in covering RAPS events or programs should contact Zachary Brousseau, senior manager of communications, at zbrousseau@raps.org or by calling +301 770 2920 ext. 245.

Press Releases

500+ gather in Amsterdam for Euro Convergence, RAPS’ largest-ever European event

Posted 12 May 2022 | By Zachary Brousseau 

RAPS today wrapped up the final day of Euro Convergence 2022, which took place live and in-person in Amsterdam after being held virtually the previous two years and drew more than 500 particip...

RAPS Euro Convergence features speakers from EMA, FDA, and Swiss, Austrian and UK health authorities, as well as notified bodies

Posted 24 March 2022 | By Zachary Brousseau 

Prominent officials from EMA, FDA, Swiss, Austrian and UK national health authorities, and several notified bodies will speak at the upcoming RAPS Euro Convergence. The annual three-day confer...

FDA continues co-sponsorship of MedCon conference with AFDO/RAPS Healthcare Products Collaborative

Posted 17 March 2022 | By Zachary Brousseau 

FDA will continue its longstanding co-sponsorship of the MedCon conference. With a focus on fostering open discussions of the most pressing issues facing the medical device industry, the AFDO/...

132 professionals pass Regulatory Affairs Certification (RAC) exams, earning RAC-Devices or RAC-Drugs credentials

Posted 10 March 2022 | By Zachary Brousseau 

RAPS today announced the names of the 132 professionals who passed one of the two Regulatory Affairs Certification (RAC) exams in autumn 2021. By passing, they earn either the RAC-Drugs or RAC...

RAPS and AFDO partner to further healthcare products industry dialogue, including MedCon conference

Posted 28 February 2022 | By Zachary Brousseau 

RAPS and the Association of Food and Drug Officials (AFDO) have come together to support sharing, collaboration and learning across the global healthcare products community. With a focus on fo...

RAPS in the News

Dearth of Participation From Black Patients Noted in CAR T Clinical Trials Supporting FDA Approvals | Cancer Network

Posted 09 May 2022 | By Ariana Pelosci

Investigators identified that in pivotal clinical trials supporting FDA approvals of CAR T-cell therapies for patients with hematologic cancer, Black patients were significantly underrepresented.

MedCon: Industry praises FDA’s digital health Pre-Cert pilot | Hebdenbridge News

Posted 06 May 2022

Stakeholders in a session at MedCon 2022 expressed largely positive sentiments about their experience with the US Food and Drug Administration’s (FDA) Digital Health Software Precertification (Pre-Cert) Program.

FDA Draft Guidance Would Set In Stone Case For Quality Voluntary Improvement Program | MedTech Insight

Posted 05 May 2022 | By Shawn M. Schmitt

The draft document from the US agency looks to officially recognize a program aimed at advancing quality in medical devices and their manufacturing.

FDA loosens review process for certain orthopedic devices | Becker's Spine Review

Posted 12 April 2022 | By Alan Condon

The FDA has issued two guidelines that make it less complex for medtech companies to commercialize orthopedic devices and sutures using its safety and performance-based pathway, according to the Regulatory Affairs Professionals Society.