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USFDA Guidance: Hemodialysis Blood Tubing Sets – Premarket Notification (510(k)) Submissions
Hemodialysis blood tubing sets are critical components of the extracorporeal blood circuit used during hemodialysis treatment. Manufacturers submitting a Premarket Notification (510(k)) for these devices should provide sufficient information to demonstrate that the device is safe, effective, and substantially equivalent to a legally marketed predicate device. The Hemodialysis Blood Tubing Sets – Premarket Notification (510(k)) Submissions outlines recommendations for device d
Sharan Murugan
3 days ago3 min read
UK MHRA Guidance: Medical Devices That Need a Clinical Investigation and Clinical Investigations for Medical Devices
Clinical investigations play an important role in generating clinical evidence to demonstrate the safety, performance, and clinical benefit of medical devices before they are placed on the market. Manufacturers and sponsors must determine when a clinical investigation is required and follow the appropriate notification procedures before commencing a study in Great Britain. The guidance documents Medical Devices That Need a Clinical Investigation and Clinical Investigations fo
Sharan Murugan
3 days ago2 min read
UK MHRA Guidance: Clinical Investigations in Great Britain, Approving Clinical Investigations, and Compiling a Submission
Clinical investigations are an essential part of demonstrating the safety and performance of medical devices before they are placed on the market. Organizations conducting investigations in Great Britain must ensure that studies are appropriately planned, approved, and supported with complete regulatory documentation. The guidance documents Clinical Investigations in Great Britain, Approving Clinical Investigations, and Compiling a Submission outline the regulatory framework,
Sharan Murugan
3 days ago2 min read
Swissmedic Guidance: Quality Defect Reporting, Medical Device Registration Fees, and Clinical Investigations with Medical Devices
Switzerland's regulatory framework for medicinal products and medical devices places strong emphasis on product quality, effective market oversight, and the safe conduct of clinical investigations. Recent Swissmedic information sheets provide important requirements for pharmaceutical companies, medical device manufacturers, sponsors, investigators, and other stakeholders operating in Switzerland. This blog provides a concise overview of three Swissmedic information sheets cov
Sharan Murugan
Jul 204 min read
EMA Guidance: Qualification of Novel Methodologies for Medicinal Product Development
Innovation is transforming medicinal product development through the introduction of novel methodologies such as biomarkers, digital health technologies, artificial intelligence (AI), modelling and simulation, real-world data, patient registries, and advanced non-clinical testing methods. These approaches have the potential to improve evidence generation, streamline drug development, and support more informed regulatory decision-making. However, before they can be widely adop
Sharan Murugan
Jul 124 min read