FDA Guidance Documents
Technotes
Stay current with the latest FDA guidance documents affecting drug, biologic, device, and diagnostic development. Browse recently issued and updated guidance to identify evolving regulatory expectations, compliance considerations, and recommendations that may influence your development and testing strategies.
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled “E22 General Considerations for Patient Preference Studies.” The draft guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)....
FDA is issuing this guidance to provide recommendations on computer software assurance for computers and automated data processing systems used as part of medical device production or the quality management system. This guidance describes a risk-based approach to establish confidence in the automation used for production or quality management systems,...
This document provides FDA’s recommendations to industry regarding cybersecurity device design, labeling, and the documentation that FDA recommends be included in premarket submissions for devices with cybersecurity risk. These recommendations are intended to promote consistency, facilitate efficient premarket review, and help ensure that marketed medical devices are sufficiently resilient to...
Section 3060(a) of the 21st Century Cures Act (Cures Act), enacted on December 13, 2016, amended section 520 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) to exclude certain medical software functions, including certain decision support software, from the definition of device under section 201(h) of the FD&C...
This draft guidance document provides the FDA’s recommendations on clinical performance testing and evaluation to support premarket submissions for cuffless non-invasive blood pressure measuring devices. The recommendations reflect current review practices and are intended to promote consistency and facilitate efficient review of cuffless non-invasive blood pressure measuring device submissions....
This guidance provides recommendations to sponsors about using minimal residual disease (MRD) and complete response (CR) in multiple myeloma as primary endpoints in trials evaluating drug and biological products intended to treat patients with multiple myeloma (MM) to support approval under accelerated approval. For the purpose of this guidance, the...
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled “M4Q(R2) The Common Technical Document for the Registration of Pharmaceuticals for Human Use: Quality.” The draft guidance was prepared under the auspices of the International Council for Harmonisation of Technical...
This draft guidance provides guidance to sponsors and applicants submitting investigational new drug applications (INDs), new drug applications (NDAs), biologics licensing applications (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...
The Food and Drug Administration (FDA) is issuing this guidance document to provide clarity to industry and FDA staff on the Center for Devices and Radiological Health's (CDRH's) compliance policy for low risk products that promote a healthy lifestyle (general wellness products).1 This guidance does not apply to products (e.g.,...
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled “Formal Dispute Resolution and Administrative Hearings of Final Administrative Orders Under Section 505G of the Federal Food, Drug, and Cosmetic Act.” This guidance provides recommendations for industry and review staff on...
