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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final guidances for which the center is interested in receiving external feedback on whether they should be revised or withdrawn.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