The FDA released draft guidance on the content and formatting of Instructions for Use (IFU) for prescription drugs, biologics, and drug- or biologic-device combinations. Read More
Health Canada issued new guidance on its premarket requirements for medical device cybersecurity. Read More
Device association MedTech Europe released a seven-point plan to help EU member states tackle the looming MDR/IVDR implementation deadlines. Read More
The FDA rapped three devicemakers for a variety of violations including complaint handling, validations and failure to establish procedures for process changes. Read More
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