US FDA

Small Entity Compliance Guide: Laboratory Developed Tests The U.S. Food and Drug Administration (FDA) have issued a Small Entity Compliance Guide (SECG) to assist small entities in complying with FDA regulations as they apply to in vitro diagnostic (IVD) products, including laboratory developed tests (LDTs). The LDT final rule published on May 6, 2024, amends the FDA’s regulations to make…

Importing H5 Avian Influenza Samples On June 6, the Federal Select Agent Program announced a new H5 Avian Influenza Virus Exemption. The Administrator of the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) has utilized his exemption authority under 9 C.F.R. 121.5(f) in the select agent and toxin regulations to temporarily exempt H5 avian influenza viruses…

FDA Webinar: Enforcement Policies for Certain In Vitro Diagnostic Devices - Draft Guidances The U.S. Food and Drug Administration (FDA) is announcing a webinar to discuss draft guidances: Enforcement Policy for Certain In Vitro Diagnostic Devices for Immediate Public Health Response in the Absence of a Declaration under Section 564,when finalized, will describe the FDA’s enforcement policy for certain laboratory…

FDA Takes Action to Help Ensure the Safety and Effectiveness of Laboratory Developed Tests Page Summary: On 29 April, the U.S. Food and Drug Administration took action aimed at helping to ensure the safety and effectiveness of laboratory developed tests, or LDTs, which are used in a growing number of health care decisions and about which concerns have been raised…

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…

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…

The US FDA have published 510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review Draft Guidance for Industry, Food and Drug Administration Staff, and Third Party Review Organizations This draft guidance outlines FDA's current thinking on key aspects of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…

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…

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…