Day

October 3, 2011
HealthCanada released “Guidance Document for Mandatory Problem Reporting for Medical Devices” on October 3, 2011. Mandatory problem reporting is intended to “improve monitoring and reduce the recurrence of incidents related to medical devices.” A mandatory problem report is required for any incident involving a medical device when the incident “relates to a failure of the...
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What’s New

FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:  https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/exemptions-variances-and-alternate-forms-adverse-event-reporting-medical-devices

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