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  Considerations for Including Tissue Biopsies in Clinical Trials

  The U.S. Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP) have released a draft guidance document, Considerations for Including Tissue Biopsies in Clinical Trials, issued in January 2025. It provides recommendations for sponsors, investigators, institutions, and Institutional Review Boards (IRBs) on the safe and ethical incorporation of tissue biopsies in clinical trials.

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  5 Key Features of FDA Draft Guidance for Predetermined Change Control Plans (PCCPs) for Medical Devices

  Predetermined Change Control Plans (PCCPs) Draft Guidance with Implications for Medical Device Manufacturers and regulatory framework

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  Impact of FDA Laboratory Developed Tests Policy

  The U.S. Food and Drug Administration (FDA) made a significant update to its regulatory approach for in vitro diagnostic products (IVDs), including laboratory developed tests (LDTs). Detailed in a FDA Laboratory Developed Tests Policy guidance document issued on June 25, 2024.

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  Gender Equity in Medical Devices: Bridging the Data Gap

  Gender data gap’s implications on women’s health and strategic measures for its integration into gender gap medical devices, regulatory frameworks and design processes.

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  5 Key Points in FDA’s Real-World Evidence Draft Guidance

  FDA Real-World Evidence Draft Guidance analysis identifies five key points to help understand the potential impact of the draft guidance.

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  FDA’s Draft Guidance on Decentralized Clinical Trials: Analysis

  Analysis of FDA draft guidance “Decentralized Clinical Trials for Drugs, Biological Products, and Devices.”

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  FDA and Health Canada streamline medical device submissions with joint eSTAR portal

  Overview of eSTAR, a joint Health Canada and FDA program streamlining medical device submissions with info on how to apply for the program.

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  Writing Effective SOPs for Manufacturing Medical Devices

  Writing and implementing standard operating procedures (SOPs) for the manufacture of medical devices is required by ISO 13485, FDA, and other regulatory bodies. An SOP is a set of written instructions that documents a routine or repetitive activity that is followed by employees in an organization. The development and use of SOPs are integral parts of a successful quality system. They provide directions to perform a job properly and consistently to achieve predetermined specifications and quality end results. SOPs address all requirements to complete the job or process safely and effectively.

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  Preparing EUA Medical Devices for Post-Pandemic Use

  Review of the FDA transition plan for medical devices currently marketed under Emergency Use Authorizations with implications for devices.

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