Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Forty-five documents have been posted on the tracker since its last update.
Forty-five guidance documents on medical devices and diagnostics issued by regulatory authorities from around the world were added to Medtech Insight’sGuidance Tracker in the past month.
The updated tracker includes guiding principles jointly developed by regulators in the US, Canada and the UK regulators on predetermined change control plans (PCCP) for machine learning-enabled medical devices. They...
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. 25 documents have been posted on the tracker since its last update.
Recognizing that the evidence it receives in applications for health technology assessments will increasingly be informed by artificial intelligence, the CDA-AMC has clarified its expectations for companies that use AI methods in the generation and/or reporting of evidence.
The FDA's final LDT ruling was struck down in federal court last month. For now, diagnostic companies can commercialize under CLIA regulations or apply for FDA approval. McDermott and Tribun Health have shared insights on the risks, pros and cons of both regulatory routes.
Many of the hundred-plus commenters to the FDA's draft guidance on AI in medical product regulation said the document was a good start but needed additional clarity and more concrete examples. Stakeholders recommended the inclusion of case studies, metrics, and clearer guidelines to enhance the utility of the guidance, which is seen as a vital step for AI integration in healthcare.
Manufacturers of medical products would be foolish to think that recent upheavals at the US FDA will result in a lack of inspections in the coming years. A panel of experts discussed the current state of inspections during a webinar hosted by the Food and Drug Law Institute.
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. 25 documents have been posted on the tracker since its last update.
Recognizing that the evidence it receives in applications for health technology assessments will increasingly be informed by artificial intelligence, the CDA-AMC has clarified its expectations for companies that use AI methods in the generation and/or reporting of evidence.
