BROWSE TOPICS HOME Regulatory Affairs


10/27/2017

Big Names in Tech Included in FDA Digital Health Pilot

10/27/2017

FDA Qualifies First Medical Device Development Tool

10/24/2017

FDA Guidance Seeks to Get Technology to Patients Faster

9/28/2017

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

9/28/2017

Leaving TJC, Mills Reflects on His Career

9/27/2017

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

8/31/2017

FDA Promotes 'Greater Use' of Standards for Medical Devices

8/30/2017

Congress Requires FDA to Address Device Service

8/30/2017

The Big Picture: FDA Leveraging/Collaboration Award

8/29/2017

FDA Recognizes Wireless Coexistence TIR, Four AAMI Standards

8/28/2017

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

8/18/2017

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

8/14/2017

FDA Finalizes Guidance on Medical Device Development Tools

8/7/2017

FDA Releases Plan for Digital Health Regulation

7/28/2017

FDA Patient Engagement Advisory Committee to Tackle Challenge of Clinical Trials

7/25/2017

FDA Promotes ‘Greater Use’ of Standards for Medical Devices

7/12/2017

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

6/28/2017

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

6/19/2017

FDA Commissioner Announces Risk-Based Plan for Digital Health Technology

5/31/2017

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

5/30/2017

Lawmakers Dive Into Device Service Debate

5/23/2017

VIDEO: Shifting Global Regulations Hit Medical Device Manufacturers

5/17/2017

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

5/3/2017

U.K. Regulator Stresses Need for Global Harmonization

5/3/2017

Manufacturers Prepare for Regulatory 'Tsunami'

4/10/2017

Shifting Global Regulations to Hit Home for Medical Device Manufacturers

3/23/2017

FDA Delays Intended Use Rule, Seeks Public Comment

2/8/2017

Federal Court Upholds Copyright Protections for Standards Organizations

11/13/2013

FDA Report Examines Personalized Medicine