Regulatory Focus

Boston – Regulators from the US and UK discussed ongoing efforts to develop regulatory frameworks that are better suited to generative artificial intelligence (genAI) products at The MedTech Conference on Tuesday.

The US Food and Drug Administration (FDA) on Tuesday finalized guidance to address how sponsors can develop, distribute, and label software applications (apps) used alongside prescription medicines. These can include apps that are used with asthma inhalers or stand-alone symptom trackers, dose reminders, or health coaching tools.

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BOSTON – Despite some early jitters, the medtech industry is coming around to the Quality Management System Regulation (QMSR), according to a top industry executive who spoke at The MedTech Conference on Monday.

Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has published “review points” for medical devices using generative AI.

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.

Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical device regulation, and what we’re reading from around the web. This week, there are reports that some staff are concerned that a new HHS performance assessment could be a prelude to more layoffs, former FDA chiefs criticized last year’s mass firings, and more.

At some advisory committee meetings, more than half of patient and consumer representatives who attended had connections to organizations with these active ties to industry.