Policy for Device Software Functions and Mobile Medical Applications
Policy for Device Software Functions and Mobile Medical Applications guidance to communicate how the Agency intends to apply its regulatory oversight to certain software, including device software functions and mobile medical applications (MMAs) intended for use on mobile platforms or on general-purpose computing platforms. FDA intends to apply its regulatory oversight to those device software […]
Medical Device Data Systems Medical Image Storage Devices and Medical Image Communications Devices
Medical Device Data Systems Medical Image Storage Devices and Medical Image Communications Devices guidance to communicate how the Agency intends to apply its regulatory oversight to medical device data systems (MDDS), medical image storage devices, and medical image communication devices. FDA does not intend to enforce the requirements of the Federal Food Drug and Cosmetic […]
FDA and Industry Actions on Premarket Approval Applications (PMAs): Effect on FDA Review Clock and Goals
FDA and industry action on Premarket Approval Application (PMAs): Effect on FDA review Clock and Goals. The Medical Device User Fee Amendments of 2022 (MDUFA V) amended the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to authorize FDA to collect user fees for the review of certain premarket submissions received on or after […]
Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) – Small Entity Compliance Guide
Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) – Small Entity Compliance Guide guidance in accordance with section 212 of the Small Business Regulatory Enforcement Fairness Act (Public Law 104-121). It is intended to help small entity establishments that manufacture human cells, tissues, or cellular or tissue-based products (HCT/Ps) better understand the […]
Studying Multiple Versions of a Cellular or Gene Therapy Product in an Early-Phase Clinical Trial
Studying Multiple Versions of a Cellular or Gene Therapy Product in an Early-Phase Clinical Trial guidance is to provide recommendations to sponsors interested in studying multiple versions of a cellular or gene therapy product in an early-phase clinical trial for a single disease. Sponsors have expressed interest in gathering preliminary evidence of safety and activity using […]
Enforcement Policy Regarding Investigational New Drug Requirements for Use of Fecal Microbiota for Transplantation to Treat Clostridium difficile Infection Not Responsive to Standard Therapies
Enforcement Policy Regarding Investigational New Drug Requirements for Use of Fecal Microbiota for Transplantation to Treat Clostridium difficile Infection Not Responsive to Standard Therapies dated March 2016, and supersedes the guidance entitled “Enforcement Policy Regarding Investigational New Drug Requirements for Use of Fecal Microbiota for Transplantation to Treat Clostridium difficile Infection Not Responsive to Standard […]
Failure to Respond to an ANDA Complete Response Letter Within the Regulatory Timeframe Guidance for Industry
Failure to Respond to an ANDA Complete Response Letter Within the Regulatory Timeframe Guidance for Industry guidance is intended to assist applicants of abbreviated new drug applications (ANDAs), which were submitted under section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)), in responding to complete response letters (CRLs) from […]
Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act Guidance for Industry
Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act Guidance for Industry this document given by FDA. The Drug Supply Chain Security Act (DSCSA) (Title II of Public Law 113-54) amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) to establish requirements for product tracing, verification, […]
Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biological Products
Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biological Products guidance describes FDA’s current recommendations regarding adjusting for covariates in the statistical analysis of randomized clinical trials in drug development programs. This guidance provides recommendations for the use of covariates in the analysis of randomized, parallel group clinical trials that are applicable to […]