BROWSE TOPICS HOME Regulatory Affairs


Feb 3, 2020

FDA Exempts Some Devices from Premarket Notification

Feb 3, 2020

First Fully Disposable Duodenoscope Receives FDA Clearance

Feb 3, 2020

Medical Device Community Braces for Brexit

Feb 3, 2020

Taiwan FDA Discusses Cardiac Implant Standards

Dec 1, 2019

FDA Guidance Describes Process for Requesting Review of Denied Export Certificates

Nov 4, 2019

FDA Outlines Details of Proposed ASCA Pilot Program

Nov 1, 2019

FDA Encourages Patient Engagement in Device Development

Nov 1, 2019

News in Brief

Nov 1, 2019

A Quality System for Better Imaging Device Repair

Nov 1, 2019

FDA Outlines 2020 Guidance Priorities

Nov 1, 2019

Are Today’s Regulatory Paradigms Fit for the Future?

Oct 8, 2019

Medical Devices at Risk of 'Urgent/11' Vulnerability

Sep 9, 2019

New TIR Helps Industry Meet Global Quality Management Expectations

Aug 27, 2019

New Type of AAMI Resource Aims to Address Need for Rapid Guidance

Aug 20, 2019

NIST Urges Federal Commitment to Development of AI Standards

Aug 7, 2019

FDA Expands MRI Safety Recommendations in Draft Guidance

Aug 2, 2019

FDA Increases User Fees for 2020

Jul 30, 2019

FDA Releases Final Guidance on Postmarket Safety Reports for Combination Products

Jul 23, 2019

Federal Engagement in AI Standards Detailed in NIST Draft Plan

Jul 22, 2019

FDA Recognizes AAMI Standard and TIR

Jun 26, 2019

FDA Closes Alternative Summary Reporting Program

Jun 19, 2019

TJC Updates PM 'Grace Period' Guidance Presented at Exchange

Jun 10, 2019

Sense of Urgency Needed in Combating Sizable Device-Related Cyberthreats

Jun 10, 2019

Massive Data Presents Challenges and Opportunity

Jun 9, 2019

Importance of 'Defensible' Policies Key Theme of TJC Update

Jun 9, 2019

Leveraging AI for the Benefit of Accurate, Efficient Health Technology Management

Jun 9, 2019

HTM Professionals Step into the ‘Shark Tank’

Jun 9, 2019

WHO Medical Device Leader Cites Global HTM Challenges, Opportunities

Jun 8, 2019

Medical Device Integration Team Solves Challenge of Monitoring Private ICU Rooms

Jun 8, 2019

It’s Time to ‘Think Big’ and ‘Embrace Disruption’

Jun 7, 2019

FDA Seeks to Publish Guidance on Servicing, Remanufacturing of Devices by Fall 2019

Jun 7, 2019

Entrepreneurs ‘Xcelerate’ Innovation at Pitch Competition

May 31, 2019

Two Years Later, WannaCry Remains an 'Unmanageable' Threat

May 24, 2019

Winning HTM Week Videos Offer Creative Look at Work of Biomeds

May 22, 2019

Microsoft ‘BlueKeep’ Vulnerability Exposes Medical Devices to Potential Cyberattacks

May 17, 2019

A Conversation with the BMET of the Year

May 10, 2019

FDA Issues Final Guidance for Feedback Program

May 6, 2019

FDA Seeks Feedback on Patient Preferences Related to Medical Devices

Apr 23, 2019

HHS Plans for ‘Nationwide Interoperability’

Apr 19, 2019

How HTM Professionals Can Master the Medical Internet of Things

Apr 17, 2019

Jagger’s Heart Procedure Gives Standards Developers 'Satisfaction'

Apr 3, 2019

FDA Develops Framework for the Future of AI Regulation

Apr 3, 2019

CDRH Proposes Greater Collaboration on International Standards

Apr 2, 2019

FDA Proposes Uniform Inspection Guidelines

Mar 26, 2019

FDA to Scrutinize Implantable Medical Device Materials

Mar 19, 2019

CDRH Begins Major Reorganization Effort

Mar 12, 2019

Medical Device Industry Rattled by Gottlieb Resignation

Mar 6, 2019

FDA Commissioner Scott Gottlieb Announces Resignation

Feb 26, 2019

Draft Guidance ‘Leapfrogs’ FDA into Regulation of Brain–Computer Interfaces

Feb 19, 2019

Public-Private Partnership Provides ‘Security Roadmap’ for Health Technology

Feb 5, 2019

FDA Workshop Tackles Ongoing Cybersecurity Concerns

Feb 5, 2019

FDA Looks to Future after ‘Record’ Year

Jan 29, 2019

FDA Recognizes 138 Consensus Standards

Jan 3, 2019

Benefits of Unregulated Digital Health Tools Outweigh Risks, FDA Says

Jan 2, 2019

FDA to End Extended GUDID Grace Period

Oct 2, 2018

FDA Announces Special 510(k) Program Pilot

Sep 18, 2018

FDA Updates Guidance on Voluntary Consensus Standards

Sep 14, 2018

FDA Plans to Streamline Third-Party 510(k) Reviews

Sep 6, 2018

FDA Issues Draft Guidance on Considering Uncertainty in Device Submissions

Aug 21, 2018

FDA Examines Barriers to Pediatric Technology Development

Aug 7, 2018

FDA User Fees Set to Rise in 2019

Aug 2, 2018

FDA Issues Final Guidance on Use of EHR Data in Clinical Investigations

Jul 27, 2018

FDA Approves First Smartphone Camera-Based Device for Clinical Diagnostics

Jul 24, 2018

Global Regulators Promote UDI Standardization with New Guide

Jul 18, 2018

Industry Provides Mixed Reaction to ‘Modernized’ 510(k) Premarket Clearance Program

Jun 26, 2018

FDA Updates Pre-Cert Program Framework, Seeks Additional Input

Jun 1, 2018

FDA’s Medical Device Service Report Brings Relief but Questions Remain

May 15, 2018

FDA Rejects Push for New Regulatory Action on Medical Device Service

May 10, 2018

FDA to Shift Focus to International Standard, Replacing Quality System Regulation

May 2, 2018

FDA Moves to Put Digital Health Plan into Action

Apr 20, 2018

FDA Warns of Endoscope Connector Contamination Risk

Apr 20, 2018

FDA Action Plan Promotes Innovation to Make Medical Devices Safer

Apr 17, 2018

Draft Brexit Agreement Provides Little Clarity for E.U. Device Manufacturers

Apr 17, 2018

FDA Guidance Looks to ‘Modernize’ 510(k) Premarket Clearance Program

Mar 27, 2018

FDA Delays Enforcement of Certain Combination Product Reporting Requirements

Mar 26, 2018

FDA Considering Updates to Quality System Requirements

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