discussion paper

Discussion Paper:
Health Equity For Medical Devices

The U.S. Food and Drug Administration’s (FDA’s) Center for Devices and Radiological Health (CDRH) has developed a discussion paper, Health Equity For Medical Devices, and seeks input from the public…

The U.S. Food and Drug Administration’s (FDA’s) Center for Devices and Radiological Health (CDRH) has developed a discussion paper, Health Equity For Medical Devices, and seeks input from the public…

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EU Commission

Q2/2024 Life Science Law Update:
Key developments for pharma & device companies in EU

The Q2/24 Life Science and Health Care Law Update covers key trends in the EU and Big Five (France, Germany, Italy, Spain, UK) in life sciences regulatory, corporate, compliance, competition,…

The Q2/24 Life Science and Health Care Law Update covers key trends in the EU and Big Five (France, Germany, Italy, Spain, UK) in life sciences regulatory, corporate, compliance, competition,…

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Bridging Regulatory & Reimbursement

Everybody is looking for Evidence — Bridging Regulatory & Reimbursement: Strategies for Success

By Christy Sheehy, PhD, Jenny Levinson

…plan ahead for market access. Our industry develops innovative products to improve human health, and reimbursement gives patients access to these life-changing medical technologies.   1 https://medtechintelligence.com/news_article/fda-issues-updated-draft-guidance-on-use-of-real-world-evidence/ 2 https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-and-machine-learning-aiml-enabled-medical-devices#resources 3…

…plan ahead for market access. Our industry develops innovative products to improve human health, and reimbursement gives patients access to these life-changing medical technologies.   1 https://medtechintelligence.com/news_article/fda-issues-updated-draft-guidance-on-use-of-real-world-evidence/ 2 https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-and-machine-learning-aiml-enabled-medical-devices#resources 3…

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FDA

Safe harbor for voluntary corrections of drug or device “misinformation” clarified in FDA guidance

By Hogan Lovells Engage

…timely, digestible, factual information to news media and other organizations; Creating resources on FDA’s website and social media to address common questions about the products the agency regulates; Participating in…

…timely, digestible, factual information to news media and other organizations; Creating resources on FDA’s website and social media to address common questions about the products the agency regulates; Participating in…

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Regulatory Survey 2024

SURVEY: Managing global regulatory strategy and compliance – assessing status, gaps, and needs.

By Celegence, MedTech Intelligence Staff

More resources, expertise, and technology, please! The common theme illustrated in a recent survey among medical device regulatory professionals is the need for increased resources, expertise, and technology. The data…

More resources, expertise, and technology, please! The common theme illustrated in a recent survey among medical device regulatory professionals is the need for increased resources, expertise, and technology. The data…

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FDA

FDA publishes long-awaited clinical trial diversity guidance

By Hogan Lovells Engage

From our publishing partner:   The U.S. Food and Drug Administration (FDA) has issued its long-awaited draft guidance, “Diversity Action Plans to Enrollment of Participants from Underrepresented Populations in Clinical…

From our publishing partner:   The U.S. Food and Drug Administration (FDA) has issued its long-awaited draft guidance, “Diversity Action Plans to Enrollment of Participants from Underrepresented Populations in Clinical…

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LDT-laboratory Developed Test

FDA under fire: Pared-down LDT Final Rule leaves unanswered questions

By Hogan Lovells Engage

The U.S. Food and Drug Administration (FDA) has finalized its historic — and notoriously controversial — rule to explicitly assert the agency’s authority to regulate laboratory developed tests (LDTs). Below…

The U.S. Food and Drug Administration (FDA) has finalized its historic — and notoriously controversial — rule to explicitly assert the agency’s authority to regulate laboratory developed tests (LDTs). Below…

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Combination Devices: new guidance for industry and notified bodies

Revision of Guidance: A new revision of the guidance available to applicants, marketing authorisation holders and notified bodies of medical devices has been published today. This question-and-answer document provides practical…

Revision of Guidance: A new revision of the guidance available to applicants, marketing authorisation holders and notified bodies of medical devices has been published today. This question-and-answer document provides practical…

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Healthcare Technology

The Role of EPSS in Prioritizing IoMT Security Threats

By Shankar Somasundaram

…the most.   References: [i] “Unpatched and Outdated Medical Devices Provide Cyber Attack Opportunities,” Federal Bureau of Investigation, September 12, 2022, https://www.ic3.gov/Media/News/2022/220912.pdf [ii] “The EPSS Model,” FIRST, https://www.first.org/epss/model [iii] “Exploit…

…the most.   References: [i] “Unpatched and Outdated Medical Devices Provide Cyber Attack Opportunities,” Federal Bureau of Investigation, September 12, 2022, https://www.ic3.gov/Media/News/2022/220912.pdf [ii] “The EPSS Model,” FIRST, https://www.first.org/epss/model [iii] “Exploit…

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Errol Weiss

Information Sharing: A Valuable Tool in Preventing Cyber Attacks

By MedTech Intelligence Staff

…as much because it’s not creating headline news. To answer the question, ransomware is all about money. They don’t care who they’re attacking. They are opportunistic. They launch attack and…

…as much because it’s not creating headline news. To answer the question, ransomware is all about money. They don’t care who they’re attacking. They are opportunistic. They launch attack and…

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