BROWSE TOPICS HOME Regulatory Affairs

Feb 20, 2018

FDA Sets ‘Good Clinical Practice’ Bar for Clinical Data Generated Outside U.S.

Feb 5, 2018

E.U. Proposes Union-Wide Health Technology Assessments

Jan 22, 2018

CDRH Outlines ‘Holistic Approach’ with 2018–2020 Strategic Priorities

Jan 16, 2018

FDA Delays UDI Enforcement for Some Lower-Risk Devices

Jan 2, 2018

FDA Prepares for ‘Wave of New Technologies’ as 3D Printing Takes Off for Devices

Jan 2, 2018

FDA Commits to Modernizing Reviews, Promoting Innovation in 2018

Dec 28, 2017

FDA Proposes Program to More Efficiently Report Medical Device Malfunctions

Dec 21, 2017

FDA Says Early Clinical Research of Medical Devices Coming Back to U.S.

Dec 14, 2017

FDA Draws Line between Regulated and Unregulated Digital Health Products

Dec 13, 2017

FDA Commits to Modernizing Reviews, Promoting Innovation in 2018

Dec 8, 2017

FDA Prepares for ‘Wave of New Technologies’ as 3D Printing Takes Off for Devices

Oct 27, 2017

Big Names in Tech Included in FDA Digital Health Pilot

Oct 27, 2017

FDA Qualifies First Medical Device Development Tool

Oct 24, 2017

FDA Guidance Seeks to Get Technology to Patients Faster

Sep 28, 2017

FDA Says Digital Health Regulation Won't Be Bound by Tradition

Sep 28, 2017

Leaving TJC, Mills Reflects on His Career

Sep 27, 2017

Apple, Fitbit, Johnson & Johnson to Participate in FDA’s Digital Health Pilot Program

Aug 31, 2017

FDA Promotes 'Greater Use' of Standards for Medical Devices

Aug 30, 2017

Congress Requires FDA to Address Device Service

Aug 30, 2017

The Big Picture: FDA Leveraging/Collaboration Award

Aug 29, 2017

FDA Recognizes Wireless Coexistence TIR, Four AAMI Standards

Aug 28, 2017

AAMI Publishes Risk Management ‘How To’ for Medical Device Startups

Aug 18, 2017

Senate Bill Calls for Cybersecurity ‘Report Card’ on Medical Devices

Aug 14, 2017

FDA Finalizes Guidance on Medical Device Development Tools

Aug 7, 2017

FDA Releases Plan for Digital Health Regulation

Jul 28, 2017

FDA Patient Engagement Advisory Committee to Tackle Challenge of Clinical Trials

Jul 25, 2017

FDA Promotes ‘Greater Use’ of Standards for Medical Devices

Jul 12, 2017

Standards Developers Applaud ‘Public-Private Partnership’ during Capitol Hill Event

Jun 28, 2017

S3 Challenge Report (2014): A Safer, Clearer, and Faster Course to Market (pdf)

Jun 19, 2017

FDA Commissioner Announces Risk-Based Plan for Digital Health Technology

May 31, 2017

Spotlight on Standards: FDA Touts AAMI Resource on 'Wireless Coexistence'

May 30, 2017

Lawmakers Dive Into Device Service Debate

May 23, 2017

VIDEO: Shifting Global Regulations Hit Medical Device Manufacturers

May 17, 2017

With Eye on Medical Devices, FDA to Develop Accreditation System for Testing Labs

May 3, 2017

U.K. Regulator Stresses Need for Global Harmonization

May 3, 2017

Manufacturers Prepare for Regulatory 'Tsunami'

Apr 10, 2017

Shifting Global Regulations to Hit Home for Medical Device Manufacturers

Mar 23, 2017

FDA Delays Intended Use Rule, Seeks Public Comment

Feb 8, 2017

Federal Court Upholds Copyright Protections for Standards Organizations

Nov 13, 2013

FDA Report Examines Personalized Medicine