Recently Issued Guidance Documents

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• 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Equipment - Standards Specific Information for the Accreditation Scheme for Conformity Assessment (ASCA) Program; Draft Guidance for Industry, Accreditation Bodies, Testing Laboratories, and Food and Drug Administration Staff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Medical Devices - Standards Specific Information for the Accreditation Scheme for Conformity Assessment (ASCA) Program; Draft Guidance for Industry, Accreditation Bodies, Testing Laboratories, and Food and Drug Administration Staff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• The Accreditation Scheme for Conformity Assessment (ASCA) Program; Draft Guidance for Industry, Accreditation Bodies, Testing Laboratories, and Food and Drug Administration Staff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• Chemical Analysis for Biocompatibility Assessment of Medical Devices; Draft Guidance for Industry and Food and Drug Administration Staff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• Integrating Randomized Controlled Trials for Drug and Biological Products Into Routine Clinical Practice; Draft Guidance for Industry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• Incorporating Voluntary Patient Preference Information over the Total Product Life Cycle; Draft Guidance for Industry, Food and Drug Administration Staff, and Other Interested Parties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

• Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers; Guidance for Industry and Food and Drug Administration Staff
  CDRH/CBER, August 2024

• Electronic Submission Template for Medical Device De Novo Requests; Guidance for Industry and Food and Drug Administration Staff
  CDRH/CBER, August 2024

• FDA and Industry Procedures for Section 513(g) Requests for Information under the Federal Food, Drug, and Cosmetic Act; Guidance for Industry and Food and Drug Administration Staff
  CDRH/CBER, August 2024

• Predetermined Change Control Plans for Medical Devices; Draft Guidance for Industry and Food and Drug Administration Staff
  CDRH/CBER, August 2024

• Bacillus Calmette-Guérin-Unresponsive Nonmuscle Invasive Bladder Cancer: Developing Drugs and Biological Products for Treatment; Draft Guidance for Industry
  CDER/CBER, August 2024

• Container Closure System and Component Changes: Glass Vials and Stoppers; Guidance for Industry
  CDER/CBER, July 2024

• Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases; Guidance for Industry
  OCE/CDER/CBER, August 2024

• Bacillus Calmette-Guérin-Unresponsive Nonmuscle Invasive Bladder Cancer: Developing Drugs and Biological Products for Treatment; Draft Guidance for Industry
  OCE/CDER/CBER, August 2024

• Real-World Data: Assessing Electronic Health Records and Medical Claims Data To Support Regulatory Decision-Making for Drug and Biological Products; Guidance for Industry
  CDER/CBER/OCE, July 2024

• Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products Questions and Answers; Draft Guidance for Industry
  CDER/CBER, July 2024

• Recommendations for Investigational and Licensed COVID-19 Convalescent Plasma; Guidance for Industry
  CBER, July 2024

• Blood Pressure and Pulse Donor Eligibility Requirements – Compliance Policy; Guidance for Industry
  CBER, July 2024

• Purpose and Content of Use-Related Risk Analyses for Drugs, Biological Products, and Combination Products; Draft Guidance for Industry and FDA Staff
  CDER/CBER/CDRH/OCP, July 2024

• Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies; Draft Guidance for Industry
  OCE/CBER/CDER/CDRH/OMHHE/OWH, June 2024

• Essential Drug Delivery Outputs for Devices Intended to Deliver Drugs and Biological Products; Draft Guidance for Industry
  OCP/CBER/CDER/CDRH, June 2024

• Considerations in Demonstrating Interchangeability With a Reference Product: Update; Draft Guidance for Industry
  CDER/CBER, June 2024

• Considerations in Demonstrating Interchangeability With a Reference Product: Update; Draft Guidance for Industry
  CDER/CBER, June 2024

• Processes and Practices Applicable to Bioresearch Monitoring Inspections; Draft Guidance for Industry
  ORA/OCP/CBER/CDER/CDRH/CFSAN/CTP/CVM, June 2024

• Standardized Format for Electronic Submission for Marketing Applications Content for the Planning of Bioresearch Monitoring (BIMO) Inspections for Center for Biologics Evaluation and Research Submissions; Draft Guidance for Industry
  CBER, June 2024