Recently Issued Guidance Documents

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• Wholesale Distributor Verification Requirement for Saleable Returned Drug Product and Dispenser Verification Requirements When Investigating a Suspect or Illegitimate Product—Compliance Policies; Guidance for Industry
  CDER/CBER/ORA, October 2020

• Annual Status Report Information and Other Submissions for Postmarketing Requirements and Commitments: Using Forms FDA 3988 and FDA 3989 Guidance for Industry; Draft Guidance for Industry
  CDER/CBER, October 2020

• Testing for Biotin Interference in In Vitro Diagnostic Devices; Guidance for Industry
  CBER/CDRH, October 2020

• Emergency Use Authorization for Vaccines to Prevent COVID-19; Guidance for Industry
  CBER, October 2020

• FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency; Guidance for Industry, Investigators, and Institutional Review Boards
  CDER/CBER/CDRH/OCPP, September 2020

• The Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program; Guidance for Industry, Accreditation Bodies, Testing Laboratories, and Food and Drug Administration Staff
  CDRH/CBER, September 2020

• 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) Pilot Program; Guidance for Industry, Accreditation Bodies, Testing Laboratories, and Food and Drug Administration Staff
  CDRH/CBER, September 2020

• Biocompatibility Testing of Medical Devices - Standards Specific Information for the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program; Guidance for Industry, Accreditation Bodies, Testing Laboratories, and Food and Drug Administration Staff
  CDRH/CBER, September 2020

• Geriatric Information in Human Prescription Drug and Biological Product Labeling; Draft Guidance for Industry
  CDER/CBER, September 2020

• Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process"; Guidance for Industry and Food and Drug Administration Staff
  CDRH/CBER, September 2020

• Investigational COVID-19 Convalescent Plasma; Guidance for Industry
  (September 2, 2020)  CBER, September 2020

• Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products; Guidance for Industry
  (Updated August 27, 2020)  CBER, August 2020

• Recommendations to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Components; Guidance for Industry
  (Updated August 26, 2020)  CBER, August 2020

• Limited Population Pathway for Antibacterial and Antifungal Drugs; Guidance for Industry
  CDER/CBER, August 2020

• Pediatric Study Plans: Content of and Process for Submitting Initial Pediatric Study Plans and Amended Initial Pediatric Study Plans; Guidance for Industry
  CDER/CBER, July 2020

• Pregnancy, Lactation, and Reproductive Potential: Labeling for Human Prescription Drug and Biological Products-Content and Format; Draft Guidance for Industry
  CDER/CBER, July 2020

• Setting Endotoxin Limits During Development of Investigational Oncology Drugs and Biological Products; Draft Guidance for Industry
  CDER/CBER, July 2020

• Multiple Function Device Products: Policy and Considerations; Guidance for Industry and Food and Drug Administration Staff
  CDRH/CBER/OCP/CDER, July 2020

• Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products:  Minimal Manipulation and Homologous Use; Guidance for Industry and Food and Drug Administration Staff
  CBER/CDRH/OCP,  July 2020

• Providing Regulatory Submissions for Medical Devices in Electronic Format - Submissions Under Section 745A(b) of the Federal Food, Drug, and Cosmetic Act
  CDRH/CBER, July 2020

• Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices and Certain Devices Requiring Direct Marking; Immediately in Effect Guidance for Industry and Food and Drug Administration Staff
  CDRH/CBER, July 2020

• Development and Licensure of Vaccines to Prevent COVID-19; Guidance for Industry
  CBER, June 2020

• Development of Anti-Infective Drug Products for the Pediatric Population; Draft Guidance for Industry
  CDER/CBER, June 2020

• Risk Evaluation and Mitigation Strategies: Modifications and Revisions; Guidance for Industry
  CDER/CBER, June 2020

• Good Manufacturing Practice Considerations for Responding to COVID-19 Infection in Employees in Drug and Biological Products Manufacturing; Guidance for Industry
  CDER/CBER/CVM, June 2020

• Supplements for Approved Premarket Approval (PMA) or Humanitarian Device Exemption (HDE) Submissions During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency; Guidance for Industry and Food and Drug Administration Staff
  CDRH/CBER, May 2020

• Implementation of Acceptable Full-Length and Abbreviated Donor History Questionnaires and Accompanying Materials for Use in Screening Donors of Source Plasma; Guidance for Industry
  CBER, May 2020

• Implementation of Acceptable Full-Length and Abbreviated Donor History Questionnaires and Accompanying Materials for Use in Screening Donors of Blood and Blood Components; Guidance for Industry
  CBER, May 2020