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Good Machine Learning Practice for Medical Device Development: MHRA, FDA and Health Canada Guiding Principles
The U.S. Food and Drug Administration (FDA), Health Canada, and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) have jointly identified 10 guiding principles for Good Machine Learning Practice (GMLP) in medical device development. These principles aim to support the development of safe, effective, and high-quality medical devices that use artificial intelligence and machine learning (AI/ML). They address the unique challenges associated with data-driven de
Sharan Murugan
19 hours ago4 min read
USFDA Draft Guidance: Electronic Submission Template for Premarket Approval Applications (PMA) and Updates for Medical Device Submissions: Robotically-Assisted Surgical Devices
The FDA has issued two draft guidances in September 2026 covering important aspects of medical device regulatory submissions. One focuses on premarket submissions for robotically-assisted surgical devices (RASDs), while the other provides recommendations for the electronic submission of Premarket Approval (PMA) applications using the eSTAR template. These guidances highlight FDA's focus on structured technical evidence, software and cybersecurity considerations, clinical and
Sharan Murugan
Sep 263 min read
ICH M13B Guideline: Additional Strengths Biowaiver for Immediate-Release Solid Oral Dosage Forms
ICH M13B Guideline: Additional Strengths Biowaiver for Immediate-Release Solid Oral Dosage Forms The European Medicines Agency (EMA) has adopted the ICH M13B Guideline on Bioequivalence for Immediate-Release Solid Oral Dosage Forms – Additional Strengths Biowaiver, together with a related Questions and Answers (Q&A) document. The guideline provides recommendations for obtaining a biowaiver for one or more additional strengths when in vivo pharmacokinetic bioequivalence or eff
Sharan Murugan
Sep 264 min read