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Guidance

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How We Can Use the FDA’s 2022 Diversity Guidance to Make Our Clinical Trials More Inclusive

Catherine Gregor is the chief clinical trial officer at Florence Healthcare, a leading provider of clinical trial software that helps researchers collaborate and manage workflows and information. Based on her extensive experience in clinical research administration, Gregor explains how the recent US FDA guidance on diversity and inclusion in clinical trials represents a critical opportunity to make clinical research more inclusive and equitable.

Diversity & Inclusion Clinical Trials

US FDA Invites Comments On How It Collects Device Info Through Q-Sub Program

The US agency’s Q-Submission Program provides medical device manufacturers the opportunity to receive information on the regulatory process related to devices in development.

FDA Regulation

US Agencies Publish Guidance To Ensure Telehealth Access Equality

The US Departments of Health and Human Services and Justice have published guidance on protections in federal laws to help Americans with disabilities or limited English proficiency to access telehealth. The guidance coincides with the 32nd anniversary of the American with Disabilities Act.

Policy Diversity & Inclusion

Global Medtech Guidance Tracker: July 2022

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

Guidance Documents Regulation

Draft FDA Guidance Aims To Ensure Patients Understand LASIK Risks

The document would ask manufacturers to include additional plain-language labeling to ensure people considering LASIK have additional information about potential side effects and contraindications. 

Guidance Documents Regulation

Remote Regulatory Assessments Will Continue Post Pandemic, Says US FDA

The US FDA has issued guidance on how it will continue to use remote technology to assess agency regulated facilities, a practice that became popular during COVID-19 travel restrictions.

FDA Guidance Documents

US FDA Guidance On Patient Labeling Leaves Unanswered Questions For Combination Products

Final guidance does not address recommendations raised by PhRMA and others about product descriptions and incorporating human outcome factors in instructions for use.

Combination Products Guidance Documents

Masks And Gowns Off FDA Device Shortage List, But AEDs Among Devices Added

The US agency has updated it device shortage list, adding two devices to the list of products in short supply while removing two others.

FDA Durable Medical Equipment

US FDA Requests Input For New Report On Non-Device Software Functions

The US agency is seeking input in developing a report on the health benefits and risks of software functions that do not fall under the medical device definition.

FDA Innovation

Regulatory Attorney Offers Take On Telehealth Privacy Guidance

Attorney Sean Sullivan, partner at Alston & Bird’s Health Care Group, who is based in the firm’s Atlanta office, shared his expertise with Medtech Insight on the recent guidance issued by the US Department of Health and Human Services on patient privacy during telehealth visits.

Telehealth Policy

Global Medtech Guidance Tracker: June 2022

Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. More than 40 documents have been posted on the tracker since its last update.

Guidance Documents Regulation

US Regulatory Roundup, June 2022: Digital Health; Draft QMSR Stakeholder Comments; Medtech Cybersecurity

Top Medtech Insight stories from June: The head of the US FDA’s Digital Health Center of Excellence urges Congress to step up when it comes to new regulatory frameworks; more stakeholder comments on the FDA’s proposed Quality Management System Regulation are discussed; a cybersecurity expert says regulators need to go on the offensive; and more.

United States Regulation
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