Full Description

This publication describes the industry position of both manufacturers and distributors of medical devices used in the medical gas and gas equipment industry regarding 21 CFR Part 830 and associated guidance. It describes the industry's interpretation and application of the requirements for the creation and maintenance of device barcodes and the submission of the related database records in electronic format. This pub-lication should be utilized to create a firm's standard operating procedures (SOP) for compliance with the regulation.

This publication is based upon: 21 CFR Part 830 [1]; FDA's GUDID guidance [2]; and the Compressed Gas Association's (CGA) letters to FDA regarding these issues dated November 1, 2012 and July 8, 2014. This publication does not include guidance for implementation of UDI for standalone software. See 21 CFR Part 801 for guidance for standalone software.

This publication does not cover product codes BXK or NXF (i.e., gases used for calibration and other purposes). Gases included in these product codes are the subject of CGA's letters to FDA dated November 1, 2012 and July 8, 2014.

Product Details

Edition: 1st Published: 02/01/2017 Number of Pages: 12File Size: 1 file , 1000 KB