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On October 10, 2024, the US Food and Drug Administration (FDA) issued a Warning Letter to a clinical investigator due to objectionable conditions observed during a Bioresearch Monitoring (BIMO) Program inspection in 2023. The warning letter addresses multiple violations to Title 21 of the Code of Federal Regulations (CFR).
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The International Standard ISO 14155 “Clinical Investigation of Medical Devices for Human Subjects – Good Clinical Practice” outlines what is considered good clinical practice for the design, conduct, recording, and reporting of clinical investigations of medical devices in human participants. As we enter 2025, a Draft International Standard (DIS) of ISO 14155 is in the final stages of the approval process and is expected to be released within the coming months to replace the existing ISO
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In November 2024, the CRC press published the first edition of “Good Clinical Practices in Pharmaceuticals” edited by Graham P. Bunn (President of GB Consulting, LLC) and authored by multiple clinical trial professionals, including Clinical Pathways’ own Jennifer Lawyer and Sandra “Sam” Sather. The book is a compendium of information regarding the Good Clinical Practice (GCP) guidelines including the standards, methodologies, laws, and regulations.
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The guidance breaks down the roles and responsibilities of the investigator, sponsor, and Institutional Review Board (IRB) in regards to monitoring, mitigating, reporting, and evaluating protocol deviations (PDs). The investigator, who is responsible for the conduct of the trial and protection of the rights, safety, and welfare of the participants must report all PDs to the sponsor, highlighting the important PDs.
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On January 6, 2025, the International Council of Harmonisation’s ICH E6(R3) for Good Clinical Practices (GCP) reached step four of the formal ICH procedure. This means that the ICH E6(R3) draft guidelines, since its release in May of 2023, were submitted to and approved by the ICH Regulatory Members of the ICH Assembly for adoption as an ICH Harmonised Guideline replacing E6(R2).
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Medical Devices in the European Union (EU) are regulated by the Medical Device Regulation (MDR) (Regulation EU 2017/745) which supersedes the previous Medical Devices Directive (MDD)( 93/42/EEC). MDR was implemented on May 26th, 2021 with a three-year transition period. MDR requires that all manufacturers of medium to high-risk medical devices be certified by a notified body.
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The European Union, excluding Great Britain, regulates medical devices under the Medical Device Regulation (MDR) (Regulation EU 2017/745) which entered into force May 2017 and into application May 26, 2021 with a three year transition period. The MDR application date was originally planned for May 2020 but was delayed for one year due to the pandemic.
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When: September 17, 2020
Time: Live from 1-2 PM EDT
Register: HERE
Released in July 2020, ISO 14155:2020 is the third version of the standards that provides direction on how to implement GCP for medical device clinical investigations. The changes in this revision are designed to ensure that ISO standards are up to date with regulatory changes in the industry.
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Because of the COVID-19 pandemic, the European Commission announced that the implementation of the Medical Devices Regulation (MDR) will likely be delayed by one year. There are limited resources currently available to implement the MDR by the original date of May 26, 2020.
