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FDA s Center for Devices and Radiological Health has posted a list of the guidance documents it plans to publish in fiscal year 2016 as either final or draft guidances. It has also posted a list of previously issued final guidances for which the center is interested in receiving external feedback on whether they should be revised or withdrawn.
Several of these guidances could be of interest to medical device packaging professionals. CDRH asks that comments on any of these guidance documents be submitted to docket FDA-2012-N-1021.
FDA has divided the potential guidance documents that could be published as either final or draft into an A list and a B list. The A list is a list of prioritized device guidance documents that the Agency intends to publish within 12 months of the date this list is published each fiscal year, whereas the B list is a list of device guidance documents that the Agency intends to publish as resources permit each fiscal y
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Greenlight Guru Announces the Formation of Its New Regulatory Advisory Board
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Leading medical device QMS provider establishes Regulatory Advisory Board comprised of global regulatory experts
Greenlight Guru is continuing to push the ideal of harmonization and industry best practices forward through the formation of our Regulatory Advisory Board. INDIANAPOLIS (PRWEB) May 27, 2021 Greenlight Guru, the leading medical device quality management software platform, today announced the formation of its new Regulatory Advisory Board (RAB), comprised of nine veteran medical device professionals. Members of Greenlight Guru’s RAB have prior experience with regulatory bodies, including FDA and EU notified bodies, and have significant medical device industry expertise with respect to regulations, standards, and requirements impacting the medical device industry.