AAMI Standards Conference Software Session

At a half-day breakout session on the AAMI Medical Device Software Standard, the HIMA Conformance Assessment Tool, UL 1998, the FDA Off-the-shelf software guidance, and other software standards and policy initiatives for the medical device industry was presented as part of the annual AAMI International Standards Conference. FDA and several industry speakers participated. John Murray, of the FDA’s Office of Science and Technology and leader of the FDA’s Software STG, described FDA’s interest in standards for software development including a desire to decrease the software documentation required in submissions. Mr. Murray indicated that the Software STG recommended recognition of UL 1998 (a standard for software safety in programmable devices) and the specifics of their recommendation would make this the first FDA recognized software standard that would be applicable to devices with a major level of concern (hazard).

**** Slides from several of the speakers are attached in a single pdf. It currently includes the presentations by John Murray of the FDA, Alan Kusinitz of SoftwareCPR on the AAMI Software Standard, Stan Hamilton of Cytometrics on the Off-the-shelf Software Guidance, Susan Gill of UL on UL 1998, and Sherman Eagles of Medtronic on international standards related to medical device software. These are provided with the permissions of AAMI and the authors.

AAMI Stds 300 SW Presentations

AK

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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