FDA Official Lists Four Regulatory Considerations For Connected Combination Products
CDRH’s Courtney Evans explained the four unique considerations that connected combination manufacturers products should assess when working with the US FDA.
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Regulators Compare US, Japan Approaches To Digital Health
A discussion of Japanese and American digital health regulations at CRT2023 in Washington, DC, explored the similarities between the two countries and how we regulate software and connected devices.
Digital Health Regulations: A Year In Review
RQM’s Allison Komiyama and Kevin Go summarized up the year’s changes to digital health regulation and outlined what to expect in the coming year.
Device Interoperability: US FDA Details Expectations In Final Guidance
Electronic interface functionality, data-exchange factors and time synchronization are among key interoperability factors for device-makers to consider in device design and pre-market submissions, US FDA says in a final guidance document. The guidance stresses the need for developers to consider potential risks of interoperability from device conception and throughout the lifecycle.