The Food and Drug Administration’s (FDA’s) Center for Devices and Radiological Health (CDRH) has published the list of guidance documents that it intends to publish this year, as well as a list of previously issued final guidance documents that are now subject to retrospective review. For the first list, CDRH is seeking comments on the relative priority of the proposed guidance documents and the draft language used, as well as suggestions for new or different guidance documents. For the retrospective review list, the center is interested in suggestions on which of these final guidances should be revised or withdrawn.
The list of guidance documents that FDA fully intends to finalize and publish in 2017 includes two documents on the regulatory oversight of next-generation sequencing (NGS)-based tests overall, as well as guidance on NGS-based tests specifically for infectious diseases.
Comments on any or all of the guidance documents can be submitted under docket number FDA-2012-N-1021 at www.regulations.gov.