US FDA Guidance for Industry Jan-Mar 2026

DateTitle of guidance and link to documentType and level
of guidance		About the guidance
29 Jan 2026Clinical Decision Support SoftwareFinalThe purpose of this guidance is to describe FDA’s regulatory approach to CDS software functions. The Agency’s approach reflects changes to the FD&C Act made by the Cures Act, which amended section 520 and excludes certain software functions from the device definition. The focus of this guidance is to clarify the types of CDS software functions that are excluded from the definition of device by the criteria in section 520(o)(1)(E) of the FD&C Act. This guidance further clarifies that FDA’s existing digital health policies continue to apply to software functions that meet the definition of a device, including those that are intended for use by patients or caregivers. For example, some decision support software functions may be identified in other guidance documents as software functions for which, based on our current understanding of the risks of these software functions, FDA does not intend at this time to enforce compliance with applicable device requirements of the FD&C Act, including, but not limited to, premarket clearance and approval requirements.

This guidance provides many examples of how FDA intends to consider different kinds of software functions, including Non-Device CDS software functions and device software
functions.

21 Jan 2026M4Q(R2) The Common Technical Document for the Registration of Pharmaceuticals for Human Use: QualityDraft, Level 1The M4Q(R2) guideline establishes the location and structure of quality information for registration applications of all medicinal products for human use. It supports various submission types, including those referring to or consisting of master files, and applies to both initial marketing authorisation and post-approval submissions. This guideline is structured to be flexible to accommodate all types of medicinal products and their components.
12 Jan 2026Use of Bayesian Methodology in Clinical Trials of Drug and Biological ProductsDraftThis document provides guidance to sponsors and applicants submitting INDs, NDAs, BLAs, or supplemental applications on the appropriate use of Bayesian methods in clinical trials. Bayesian methods can be used in various ways in clinical trials. For example, Bayesian calculations can be used to govern the timing and adaptation rules for an interim analysis in an adaptive design, to inform design elements (e.g., dose selection) for subsequent clinical trials, or to support primary inference in a trial. The primary focus of this guidance is on the use of Bayesian methods to support primary inference in clinical trials intended to support the effectiveness and safety of drugs.
6 Jan 2026Clinical Decision Support Software

(Medical Devices) 		FinalThis guidance clarifies the scope of FDA’s oversight of clinical decision support software intended for health care professionals (HCPs) as devices. Not all clinical decision support software used in healthcare settings are devices and therefore subject to
FDA oversight as a device.

The purpose of this guidance is to describe FDA’s regulatory approach to CDS software
functions.