• 

  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  The U.S. Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP) have released a draft guidance document, Considerations for Including Tissue Biopsies in Clinical Trials, issued in January 2025.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.

• 

  FDA Final Guidance on Remanufacturing of Medical Devices: Key Takeaways and Implications

  In May 2024, the FDA released an updated guidance document to help manufacturers, third-party service providers, and healthcare facilities determine whether their modifications fall under the category of remanufacturing. This guidance enables these entities to continue ensuring patient safety, regulatory compliance, and the effectiveness of remanufactured medical devices.

• 

  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.

• 

  FDA’s Premarket Evaluation Team “hit list” for human factors guidance

  Did you know that this year FDA’s Human Factors Premarket Evaluation Team have a priority review hit-list for medical devices?

• 

  Expedited Access Pathway: timely medical devices for patients with life-threatening conditions

  Expedited Access Pathway (EAP) is promising for timely approval and access to devices for life-threatening or irreversibly debilitating conditions.

• 

  ISO 10993-1 FDA Change Could Significantly Impact your Biocompatibility Plans

  ISO 10993-1 and Biocompatibility impact on Medical Device Plans. Financial impact of additional Medical Device testing will have a cost.

There are no posts to show