The introduction of the Quality Management System Regulation (QMSR) by the US Food and Drug Administration (FDA) on 2 February 2024 marks a pivotal change, as it updates the Quality Management Systems requirements under 21 CFR part 820 to closely align with the ISO 13485:2016 standard. This change represents a major transition for medical device…
In a recent and notable development, the New Zealand government has repealed the Therapeutic Products Act 2023. This Act, which received Royal Assent on July 26, 2023, was originally intended to transform the regulatory framework for medical devices, medicines and natural health products in New Zealand. However, its repeal means a return to the older…
In today’s landscape of increasingly connected devices, the fusion of healthcare and technology offers transformative opportunities in patient care. However, this digital evolution also opens a Pandora’s box of cybersecurity vulnerabilities, particularly in medical devices. Recognising this pressing issue, the US Food and Drug Administration (FDA) recently issued new regulations aimed at mitigating these risks.…
The Therapeutic Products Bill, promising to revolutionize the regulatory landscape for therapeutic goods in New Zealand, has stirred intense discussions among experts and industry insiders. A recent event that vividly encapsulated this discourse was the New Zealand HealthTech Week, where the director of the Johner Institute New Zealand, Anne Arndt, was invited to give her…
The difference between validation and verification, especially in the context of Software as a Medical Device (SaMD), can be quite nuanced and often confuses many. This is largely due to the fact that various regulatory bodies like the FDA, and international standards such as IEC 62304 and IEC 82304-1, may use these terms in slightly…
The FDA has recently released a new draft guidance on “Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions”. This draft guidance proposes a novel and flexible regulatory approach for AI/ML-based medical devices, inviting public comments until July 3, 2023. A significant tool that can help in…