The Global Harmonization Task Force issued a guidance that provides 17 rules for device classification, according to a MassDevice report. The guidance provides rules for classification of devices and ...

Regulatory agencies are starting to catch up on their guidance agendas, including the European Union’s Medical Device Coordination Group (MDCG), which has posted a guidance for risk classification.

Recently posted comments from industry representatives, a law firm, and a patient advocacy group point to a few key sticking points in FDA draft guidance on the de novo classification process. This ...

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