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 press@raps.org.

Press Releases

A note from your RAPS Europe board chair

Posted 21 February 2023 | By

Salma Michor, the new chair of the RAPS Europe Board of Directors, outlines some of the priorities for her term.

RAPS arrives in India

Posted 16 January 2023 | By

RAPS launched a networking group in India that already features 377 discussion posts.

RAPS awards RAC credentials to 104 autumn 2022 examinees

Posted 12 January 2023 | By

Passing an RAC exam is no easy feat. Kudos to these professionals for their achievement.

RAPS Names Executive Director

Posted 14 December 2022 | By

The RAPS Board of Directors named Interim Executive Director Bill McMoil Executive Director on Wednesday.

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FDA Draft Guidance Would Set In Stone Case For Quality Voluntary Improvement Program | MedTech Insight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