Αποτελέσματα Αναζήτησης
Below is a list of resources on the use of symbols in labeling: Final Rule: Use of Symbols in Labeling. Frequently Asked Questions. FDA Voice: Using Symbols to Convey Information in...
- General Device Labeling Requirements
General Labeling Provisions. The general labeling...
- General Device Labeling Requirements
FDA assumes that the labeling of each uniquely labeled medical device can communicate the same information using -alone standsymbols or symbols with adjacent explanatory text.
Labeling regulations pertaining to medical devices are found in the following Parts of Title 21 of the Code of Federal Regulations (CFR). General Device Labeling - 21 CFR Part 801. Use of...
25 Φεβ 2020 · Updated description; Indicates a medical device that should not be used if the package has been damaged or opened and that the user should consult the Instructions for Use for additional information.
7 Οκτ 2024 · This document specifies symbols used to express information supplied for a medical device. This document is applicable to symbols used in a broad spectrum of medical devices, that are...
The use of symbols on the label as an alternative to written language is permitted in the MDR regulation: Annex 1, chapter III, 23.1. h). Symbols are efficient, cost saving and internationally understood concepts to convey the required information to the user of a medical device.
Medical devices – Symbols to be used with medical device labels, labelling, and information to be supplied. 5.4.9*. Contains biological material of human origin. Indicates a medical device that contains biological tissue, cells, or their derivatives, of human origin.