Update on CDRH laser policies and disclosures

Abstract

This presentation will describe and discuss the status of the amendments to its laser product safety standard that were proposed in 2013, and in addition, the policy guidance documents that have been published in recent years. In October 2016, the CDRH disclosed to the FDA Technical Electronic Product Safety Committee (TEPRSSC) its thoughts on needs for regulation and additional guidance on the safety of laser and other optical radiation emitting products. Specific product areas to be included will be laser pointers, laser illuminated projectors, and children’s toy laser products. It very possible that the CDRH may release additional guidance or publish for comment a new set of proposed amendments to the CDRH laser standard. If either of these happen, the documents be summarized and discussed in the presentation.This presentation will describe and discuss the status of the amendments to its laser product safety standard that were proposed in 2013, and in addition, the policy guidance documents that have been published in recent years. In October 2016, the CDRH disclosed to the FDA Technical Electronic Product Safety Committee (TEPRSSC) its thoughts on needs for regulation and additional guidance on the safety of laser and other optical radiation emitting products. Specific product areas to be included will be laser pointers, laser illuminated projectors, and children’s toy laser products. It very possible that the CDRH may release additional guidance or publish for comment a new set of proposed amendments to the CDRH laser standard. If either of these happen, the documents be summarized and discussed in the presentation.