IEC 62366 CDV-1 Amendment Draft for Review

AAMI/CDV-1 62366:2007/A1 (IEC/SC62A/826/CDV) — Medical devices – Application of usability engineering to medical devices, Amendment 1.
This amendment is out for comment and addresses legacy user interfaces and 62366 conformance for User Interfaces of Unknown Provenance (UOUP).

The 62366 amendment draft can now downloaded free from AAMI. Go to the AAMI web site at the link provided (http://marketplace.aami.org/eseries/PDFDocs/62366AD1012.pdf) or search standards for 62366.

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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