Recently Issued Guidance Documents
Should you find a Web link (URL) embedded within guidance documents that does not work or other documents posted on the FDA Web site, please try searching for the document using the document title. If you need further assistance, please go to Contact FDA.
- Recommendations to Reduce the Risk of Transfusion-Transmitted Malaria; Draft Guidance for Industry
CBER, January 2025 - Premarket Approval Application and Humanitarian Device Exemption Modular Review; Guidance for Industry and Food and Drug Administration Staff
CDRH/CBER, January 2025 - Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act; Guidance for Industry and Food and Drug Administration Staff
CDRH/CBER, January 2025 - Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations; Guidance for Industry and Food and Drug Administration Staff
CDRH/CBER/CDER, January 2025 - Considerations for the Use of Artificial Intelligence To Support Regulatory Decision-Making for Drug and Biological Products; Draft Guidance for Industry and Other Interested Parties
CDER/CBER/CDRH/CVM/OCE/OCP/OII, January 2025 - Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions and Answers; Guidance for Industry
CDER/CBER/CDRH/CVM/OC, January 2025 - Considerations for Complying with 21 CFR 211.110; Draft Guidance for Industry
CDER/CBER/CVM, January 2025 - Study of Sex Differences in the Clinical Evaluation of Medical Products; Draft Guidance for Industry
CDER/CBER/CDRH, January 2025 - Recommendations for Determining Eligibility of Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps); Draft Guidance for Industry
CBER, January 2025 - Recommendations to Reduce the Risk of Transmission of Human Immunodeficiency Virus (HIV) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps); Draft Guidance for Industry
CBER, January 2025 - Recommendations to Reduce the Risk of Transmission of Hepatitis C Virus (HCV) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps); Draft Guidance for Industry
CBER, January 2025 - Recommendations to Reduce the Risk of Transmission of Hepatitis B Virus (HBV) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps); Draft Guidance for Industry
CBER, January 2025 - Recommendations to Reduce the Risk of Transmission of Mycobacterium tuberculosis (Mtb) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps); Guidance for Industry
CBER, January 2025 - Recommendations to Reduce the Risk of Transmission of Disease Agents Associated with Sepsis by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps); Guidance for Industry
CBER, January 2025 - Combined Food and Drug Administration and Sponsor Oncologic Drugs Advisory Committee Briefing Document; Draft Guidance for Industry
OCE/CDER/CBER, December 2024 - Advanced Manufacturing Technologies Designation Program; Guidance for Industry
CDER/CBER, December 2024 - Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices; Draft Guidance for Industry
CDER/CBER/CDRH/OCE, December 2024 - Global Unique Device Identification Database (GUDID); Guidance for Industry and Food and Drug Administration Staff
CDRH/CBER, December 2024 - Accelerated Approval – Expedited Program for Serious Conditions; Draft Guidance for Industry
CDER/CBER/OCE, December 2024 - Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions; Guidance for Industry and Food and Drug Administration Staff
CDRH/CBER/CDER/OCP, December 2024 - Assessment of Ovarian Toxicity in Premenopausal Adults During Drug Development for Oncologic Products; Draft Guidance for Industry
OCE/CDER/CBER, November 2024 - Frequently Asked Questions — Developing Potential Cellular and Gene Therapy Products; Draft Guidance for Industry
CBER, November 2024 - Drug Interaction Information in Human Prescription Drug and Biological Product Labeling; Draft Guidance for Industry
CDER/CBER, October 2024 - Core Patient-Reported Outcomes in Cancer Clinical Trials; Guidance for Industry
OCE/CDER/CBER, October 2024 - Recommendations for the Development of Blood Collection, Processing, and Storage Systems for the Manufacture of Blood Components Using the Buffy Coat Method; Draft Guidance for Industry
CBER, October 2024 - Considerations for Long-Term Clinical Neurodevelopmental Safety Studies in Neonatal Product Development; Guidance for Industry
CDER/CBER/CDRH/OPT, October 2024 - Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers; Guidance for Industry
CDER/CBER/CORH/CSFAN/CDT/CVM/ORA/OCLiP/OCE, October 2024 - An Acceptable Circular of Information for the Use of Human Blood and Blood Components; Guidance for Industry
CBER, September 2024 - Basic Safety and Essential Performance of Medical Electrical Equipment, Medical Electrical Systems, and Laboratory Medical Equipment - Standards Specific Information for the Accreditation Scheme for Conformity Assessment (ASCA) Program; Draft Guidance for Industry, Accreditation Bodies, Testing Laboratories, and Food and Drug Administration Staff
CDRH/CBER, September 2024 - Biocompatibility Testing of Medical Devices - Standards Specific Information for the Accreditation Scheme for Conformity Assessment (ASCA) Program; Draft Guidance for Industry, Accreditation Bodies, Testing Laboratories, and Food and Drug Administration Staff
CDRH/CBER, September 2024 - The Accreditation Scheme for Conformity Assessment (ASCA) Program; Draft Guidance for Industry, Accreditation Bodies, Testing Laboratories, and Food and Drug Administration Staff
CDRH/CBER, September 2024 - Chemical Analysis for Biocompatibility Assessment of Medical Devices; Draft Guidance for Industry and Food and Drug Administration Staff
CDRH/CBER, September 2024 - Conducting Clinical Trials With Decentralized Elements; Guidance for Industry, Investigators, and Other Interested Parties
CDER/CBER/CDRH/OCE, September 2024 - Integrating Randomized Controlled Trials for Drug and Biological Products Into Routine Clinical Practice; Draft Guidance for Industry
CDER/CBER/OCE, September 2024 - Providing Regulatory Submissions in Electronic Format - Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications; Guidance for Industry
CDER/CBER, September 2024 Incorporating Voluntary Patient Preference Information over the Total Product Life Cycle; Draft Guidance for Industry, Food and Drug Administration Staff, and Other Interested Parties
CDRH/CBER, September 2024