This document explains: Application Of the Federal Performance Standard for Laser Products to Laser Diodes in Fiber Optics Communications
Laser diodes/fiber optics are already well established in telephony, instrumentation, video and many military applications. This rapidly expanding field needs direction on the criteria employed by the BRH in classifying and applying the Federal performance standard for laser products (21 CFR 1040.10 and 1040.11) to these varied products.
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.