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U.S. FDA weekly update (WC 22 Jan)

Medical Device Sterilization Town Hall: FDA Activities and Challenges in Reducing Reliance on Ethylene Oxide (EtO) Page Summary: On January 26, 2024, the FDA held the second in a series of medical device sterilization town halls to: Describe the FDA’s early actions to help assure sterilization capacity in the U.S. and recent activities to reduce overall EtO reliance while maintaining…
Tehelj
January 31, 2024
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U.S. FDA weekly update (WC 15 Jan)

FDA and CMS issue joint statement on LDTs Laboratory developed tests, or LDTs, help physicians make critical decisions about their patients’ care. According to the Center for Disease Control and Prevention (CDC), approximately 70% of health care decisions depend on laboratory test results. Because of the important role of laboratory tests in health care decisions, it is essential to ensure…
Tehelj
January 24, 2024
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FDA publishes a new draft guidance on 510(k) Third Party Review Program

The US FDA have published 510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review Draft Guidance for Industry, Food and Drug Administration Staff, and Third Party Review Organizations This draft guidance outlines FDA's current thinking on key aspects of the 510(k) Third Party Review Program and third party review of Emergency Use Authorization (EUA) requests by…
Tehelj
January 3, 2024
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U.S. FDA weekly update (WC 18 Dec)

FDA publishes a draft guidance on Real World evidence FDA is issuing this draft guidance to clarify how FDA evaluates real-world data (RWD) to determine whether they are of sufficient quality for generating real-world evidence (RWE) that can be used in FDA regulatory decision-making for medical devices. This draft guidance also proposes expanded recommendations to the 2017 guidance, Use of Real-World…
Tehelj
December 20, 2023
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U.S. FDA weekly update (WC 30 Oct)

FDA Establishes New Advisory Committee on Digital Health Technologies The US FDA have formed a new Advisory Committee on Digital Health Technologies (DHTs) to help address different issues related to DHTs such as artificial intelligence/machine learning (AI/ML), augmented reality, virtual reality, digital therapeutics, wearables, remote patient monitoring and software. The committee will also advise the FDA on these issues, providing…
Tehelj
November 3, 2023
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U.S. FDA weekly update (WC 23 Oct)

Webinar - Proposed Rule: Medical Devices; Laboratory Developed Tests On September 29, the U.S. Food and Drug Administration (FDA) announced a proposed rule which aims to end enforcement discretion on Laboratory Device Tests (LDTs). This means, under this proposed rule, that LDTs will be regulated a medical device and it will be covered under the requirements of Food, Drug and…
Tehelj
October 27, 2023
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U.S. FDA weekly update (WC 25 Sept)

FDA Proposes Rule Aimed at Helping to Ensure Safety and Effectiveness of Laboratory Developed Tests | FDA On September 29, the U.S. Food and Drug Administration (FDA) announced a proposed rule which aims to end enforcement discretion on Laboratory Device Tests (LDTs). This means, under this proposed rule, that LDTs will be regulated a medical device and it will be…
Tehelj
October 6, 2023
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U.S. FDA weekly update (WC 18 Sept)

Please note this is an extract of the original bulletin. CDRH Issues Updated Final Guidance on the Breakthrough Devices Program The U.S. Food and Drug Administration (FDA) issued an update to the final guidance: Breakthrough Devices Program. The updates align with the actions outlined in the FDA’s Center for Devices and Radiological Health (CDRH) Strategic Priorities to Advance Health Equity…
Tehelj
September 29, 2023
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U.S. FDA weekly update (WC 04 Sept)

Please note this is an extract of the original bulletin. FDA Issues Guidance and Requests Comments as a Part of Ongoing Efforts to Modernize the Premarket Notification Program To modernize the 510(k) Program to improve the safety of medical devices, the U.S. Food and Drug Administration (FDA) issued the following three draft guidance intended to support efforts to continue to…
Tehelj
September 15, 2023
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U.S. FDA weekly update (WC 28 Aug)

Please note this is an extract of the original bulletin. FDA to update AccessGUDID Database and OpenFDA The U.S. Food and Drug Administration (FDA) updated the fields released in the public AccessGUDID Database to include the field for Global Medical Device Nomenclature (GMDN) Code along with the status of the GMDN Code, Active or Obsolete. These new fields are available…
Tehelj
September 1, 2023