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Guidance

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National Academies Join Call For More Diversity In Trials

A new report from the National Academies of Sciences, Engineering, and Medicine issued a new report on the urgent need for better representation of underrepresented populations in clinical trials and research.

Diversity & Inclusion Clinical Trials

Exec Chat: Binah.ai CEO And Founder Discusses Racial Disparities In Clinical Trials

David Maman is the CEO and founder of Binah.ai, a provider of video-based health monitoring tools powered by artificial intelligence. Maman shared with Medtech Insight his thoughts on the FDA’s recent guidance to increase racial and ethnic diversity in clinical trials.

Exec Chats FDA

Final Guidance From FDA Recommends Study Approach For Glycemic Control Devices

The document explains how the US agency wants researchers to conduct early-stage studies of the devices, which attempt to control blood sugar through bariatric, neurostimulation, and other treatments.

Regulation Clinical Trials

FDA Draft Guidance Would Set In Stone Case For Quality Voluntary Improvement Program

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

FDA Guidance Documents

Global Medtech Guidance Tracker: April 2022

Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Thirty documents have been posted on the tracker since its last update.

Guidance Documents Regulation

FDA Updates COVID-19 Digital Health Policies And Public Health Solutions

The US Food and Drug Administration’s update includes the agency’s current policies that may support public health innovation in COVID-19-related digital health technologies and the response to the ongoing public health emergency.

FDA Guidance Documents

QUOTED. Suzanne Schwartz.

The US FDA issued a new guidance on 8 April that outlines a comprehensive approach device manufacturers can take to address cybersecurity concerns throughout the total product life cycle of their products. See what Suzanne Schwartz, director of the agency’s Office of Strategic Partnerships and Technology Innovation, said about it here.

Quoted Cybersecurity

FDA Draft Guidance Takes Aim At Racial, Ethnic Disparities In Clinical Trials

The US agency has outlined steps industry can take to ensure clinical trials include a broader representation of underrepresented racial and ethnic groups.

FDA Guidance Documents

FDA’s Schwartz Says New Draft Cybersecurity Guidance Addresses Emerging Threats

Suzanne Schwartz, director of the US FDA’s Office of Strategic Partnerships and Technology Innovation, tells Medtech Insight that recent cyberattacks have crippled hospitals networks, putting many patients at risk.

FDA Cybersecurity

Predicate Devices Not Needed For Denture Base Resin, Facet Screw System 510(k)s: FDA Guidances

The US FDA says in a pair of final guidance documents that makers of the resins and screw systems don’t have to compare their devices to already-marketed products when submitting a 510(k) to the agency for review.

Guidance Documents FDA

FDA: Guidance Documents Lay Out New Pathway For Fixation Plates And Surgical Sutures

Two new guidance documents lay out performance criteria the device types must meet for the safety- and performance-based pathway. 

Guidance Documents FDA

FDA Issues Long-Awaited Guidance On Device Security For Premarket Submissions, Seeks Industry Feedback

The US FDA’s 8 April draft guidance on device security replaces the agency’s 2018 guidance on the topic to better meet current cyber challenges.

FDA Guidance Documents
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