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.
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.
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.
FDA Draft Guidance Would Set In Stone Case For Quality Voluntary Improvement Program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.
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.
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.
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.
FDA Draft Guidance Takes Aim At Racial, Ethnic Disparities In Clinical Trials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’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.
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.
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.
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.
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