This document presents approaches to addressing the current major concerns about blood glucose monitoring devices intended for bedside use in the neonate nursery (BGM-N). It is based on: 1) current science; 2) clinical experience; 3) previous submissions from manufacturers to the Food and Drug Administration (FDA); 4) the Safe Medical Devices Act of 1990; and 5) regulations in the Code of Federal Regulations (CFR).
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.