Recently Issued Guidance Documents
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Ethical Considerations for Clinical Investigations of Medical Products Involving Children; Draft Guidance for Industry, Sponsors, and IRBs
OPT/CDER/CBER/CDRH, September 2022 -
Policy for Device Software Functions and Mobile Medical Applications; Guidance for Industry and Food and Drug Administration Staff
CDRH/CBER, September 2022 -
Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices; Guidance for Industry and Food and Drug Administration Staff
CDRH/CBER, September 2022 -
Clinical Decision Support Software; Guidance for Industry and Food and Drug Administration Staff
CDRH/CBER/CDER, September 2022 -
Electronic Submission Template for Medical Device 510(k) Submissions; Guidance for Industry and Food and Drug Administration Staff
CDRH/CBER, September 2022 -
Computer Software Assurance for Production and Quality System Software; Draft Guidance for Industry and Food and Drug Administration Staff
CDRH/CBER, September 2022 -
Quantitative Labeling of Sodium, Potassium, and Phosphorus for Human Over-the-Counter and Prescription Drug Products; Draft Guidance for Industry
CDER/CBER, September 2022 -
Submitting Documents Using Real-World Data and Real-World Evidence to FDA for Drug and Biological Products; Guidance for Industry
CDER/CBER/OCE, September 2022 -
Charging for Investigational Drugs Under an IND: Questions and Answers; Draft Guidance for Industry
CDER/CBER/OCLiP/OCE, August 2022 -
Changes to Disposable Manufacturing Materials: Questions and Answers; Guidance for Industry
CDER/CBER/CVM, July 2022 -
Human Prescription Drug and Biological Products - Labeling for Dosing Based on Weight or Body Surface Area for Ready-to-Use Containers - “Dose Banding”; Draft Guidance for Industry
CDER/CBER, July 2022 -
Instructions for Use - Patient Labeling for Human Prescription Drug and Biological Products - Content and Format; Guidance for Industry
OCP/CDER/CBER, July 2022 -
DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs; Draft Guidance for Industry
CDER/CBER/ORA, July 2022 -
Identifying Trading Partners Under the Drug Supply Chain Security Act; Draft Guidance for Industry
CDER/CBER, July 2022 -
Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments; Draft Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders
CDER/CBER/CDRH, June 2022 -
Considerations for Rescinding Breakthrough Therapy Designation; Draft Guidance for Industry
CDER/CBER/OCE, June 2022 -
Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies; Draft Guidance for Industry
CBER, June 2022 -
Electromagnetic Compatibility (EMC) of Medical Devices; Guidance for Industry and Food and Drug Administration Staff
CDRH/CBER, June 2022 -
Blood Pressure and Pulse Donor Eligibility Requirements – Compliance Policy; Draft Guidance for Industry
CBER, May 2022 -
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 May 23, 2022) CBER, May 2022 -
Risk Management Plans to Mitigate the Potential for Drug Shortages; Draft Guidance for Industry
CDER/CBER/CGMP, May 2022 -
Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors; Guidance for Industry
CDER/CBER, May 2022 -
Use of Circulating Tumor Deoxyribonucleic Acid for Early-Stage Solid Tumor Drug Development; Draft Guidance for Industry
CDER/CBER/CDRH/OCE, May 2022