US FDA Proposes Harmonization of Laser Product Performance Standard


24 June 2013

The US FDA (Food and Drug Administration) is proposing to amend the performance standard for laser products and medical laser products.  The goal is to achieve closer harmonization between the current standard and International Electrotechnical Commission (IEC) standards.

It is believe that the harmonization will better protect and promote the public health, reduce the economic burden on affected manufacturers and improve the effectiveness of FDA’s regulation of laser products.

The FDA is inviting comments from interested parties up until September 23, 2013. For further information visit http://www.gpo.gov/fdsys/pkg/FR-2013-06-24/pdf/2013-14846.pdf or contact us for more details.

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Written by complianceandrisk