Work Item
ASTM WK77015
New Practice for Machine Learning Training Dataset Structuring and Revision
1. Scope
The scope of the Committee shall be the development of standardized nomenclature and definitions of terms, test methods, recommended practices, guides, specifications and performance standards for medical and surgical materials and devices. The Committee will encourage research in this field and sponsor symposia, workshops and publications to facilitate the development of such standards. The Committee will promote liaison with other ASTM Committees and other organizations with mutual interests.
Keywords
AI; ML; GxP
Rationale
FDA has released a guidance on the need for AI/ML based systems to be regulated with increasing use of the technologies in medical devices. We would like to proactively create a GxP type document to outline how to bring, use, and update data structures in software as a medical device.
The title and scope are in draft form and are under development within this ASTM Committee.
Work Item Status
Date Initiated: 05-21-2021
Technical Contact: Gokce Yildirim
Item: 000
Ballot:
Status: