Devices Guidances

 

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• Global Unique Device Identification Database (GUDID); Guidance for Industry and Food and Drug Administration Staff
  CDRH/CBER, 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
• 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Equipment - Standards Specific Information for the Accreditation Scheme for Conformity Assessment (ASCA) Program; Draft Guidance for Industry, Accreditation Bodies, Testing Laboratories, and Food and Drug Administration Staff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Medical Devices - Standards Specific Information for the Accreditation Scheme for Conformity Assessment (ASCA) Program; Draft Guidance for Industry, Accreditation Bodies, Testing Laboratories, and Food and Drug Administration Staff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• The Accreditation Scheme for Conformity Assessment (ASCA) Program; Draft Guidance for Industry, Accreditation Bodies, Testing Laboratories, and Food and Drug Administration Staff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• Chemical Analysis for Biocompatibility Assessment of Medical Devices; Draft Guidance for Industry and Food and Drug Administration Staff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
• Incorporating Voluntary Patient Preference Information over the Total Product Life Cycle; Draft Guidance for Industry, Food and Drug Administration Staff, and Other Interested Parties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• Predetermined Change Control Plans for Medical Devices; Draft Guidance for Industry and Food and Drug Administration Staff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
• Remanufacturing of Medical Devices; Guidance for Industry, Entities That Perform Servicing or Remanufacturing, and Food and Drug Administration Staff
  CDRH/CBER, May 2024
• Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program; Draft Guidance for Industry and Food and Drug Administration Staff
  CDRH/CBER, March 2024
• Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the FD&C Act; Draft Guidance for Industry and Food and Drug Administration Staff
  CDRH/CBER, March 2024
• Select Updates for the Medical Device User Fee Small Business Qualification and Certification Guidance; Draft Guidance for Industry and Food and Drug Administration Staff
  CDRH/CBER, February 2024
• Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile; Guidance for Industry and Food and Drug Administration Staff
  CDRH/CBER, January 2024
• Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices
  CDRH/CBER, December 2023
• 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, November 2023
• Process to Request a Review of FDA's Decision Not to Issue Certain Export Certificates for Devices; Guidance for Industry and Food and Drug Administration Staff
  CDRH/CBER, November 2023
• Electronic Submission Template for Medical Device 510(k) Submissions; Guidance for Industry and Food and Drug Administration Staff
  CDRH/CBER, October 2023
• Breakthrough Devices Program; Guidance for Industry and Food and Drug Administration Staff
  CDRH/CBER, September 2023
• 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 2023
• Best Practices for Selecting a Predicate Device to Support a Premarket Notification [510(k)] Submission; Draft Guidance for Industry and Food and Drug Administration Staff
  CDRH/CBER, September 2023
• Recommendations for the Use of Clinical Data in Premarket Notification [510(k)] Submissions; Draft Guidance for Industry and Food and Drug Administration Staff
  CDRH/CBER, September 2023
• Evidentiary Expectations for 510(k) Implant Devices; Draft Guidance for Industry and Food and Drug Administration Staff
  CDRH/CBER, September 2023
• Content of Premarket Submissions for Device Software Functions; Guidance for Industry and Food and Drug Administration Staff
  CDRH/CBER/CDER/OCP, June 2023
• Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program; Guidance for Industry and Food and Drug Administration Staff
  CDRH/CBER, June 2023
• Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions; Draft Guidance for Industry and Food and Drug Administration Staff
  CDRH/CBER/CDER/OCP, April 2023
• Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers; Draft Guidance for Industry and Food and Drug Administration Staff
  CDRH/CBER, December 2022
• Referencing the Definition of "Device" in the Federal Food, Drug, and Cosmetic Act in Guidance, Regulatory Documents, Communications, and Other Public Documents; Guidance for Industry and Food and Drug Administration Staff
  CDRH/CBER, November 2022
• Developing and Responding to Deficiencies in Accordance with the Least Burdensome Provisions; Guidance for Industry and Food and Drug Administration Staff
  CDRH/CBER, October 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
• Computer Software Assurance for Production and Quality System Software; Draft Guidance for Industry and Food and Drug Administration Staff
  CDRH/CBER, September 2022
• Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices, Direct Marking, and Global Unique Device Identification Database Requirements for Certain Devices; Guidance for Industry and Food and Drug Administration Staff
  CDRH/CBER, July 2022
• Electromagnetic Compatibility (EMC) of Medical Devices; Guidance for Industry and Food and Drug Administration Staff
  CDRH/CBER, June 2022
• Supplements for Approved Premarket Approval (PMA) or Humanitarian Device Exemption (HDE) Submissions During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (Revised); Guidance for Industry and Food and Drug Administration Staff
  CDRH/CBER, May 2022
• Patient Engagement in the Design and Conduct of Medical Device Clinical Investigations; Draft Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders
  CDRH/CBER,  January 2022
• Principles for Selecting, Developing, Modifying, and Adapting Patient-Reported Outcome Instruments for Use in Medical Device Evaluation; Guidance for Industry and Food and Drug Administration Staff, And Other Stakeholders
  CDRH/CBER, January 2022
• Study Data Technical Conformance Guide - Technical Specifications Document
  CDRH/CBER, November 2021
• User Fees and Refunds for De Novo Classification Requests; Guidance for Industry and Food and Drug Administration Staff
  CDRH/CBER, October 2021
• FDA and Industry Actions on De Novo Classification Requests: Effect on FDA Review Clock and Goals; Guidance for Industry and Food and Drug Administration Staff
  CDRH/CBER, October 2021
• De Novo Classification Process (Evaluation of Automatic Class III Designation); Guidance for Industry and Food and Drug Administration Staff
  CDRH/CBER, October 2021
• Acceptance Review for De Novo Classification Requests: Guidance for Industry and Food and Drug Administration Staff
  CDRH/CBER, October 2021
• Unique Device Identification System: Form and Content of the Unique Device Identifier (UDI); Guidance for Industry and Food and Drug Administration Staff
  CDRH/CBER July 2021
• Safer Technologies Program for Medical Devices; Guidance for Industry and Food and Drug Administration Staff
  CDRH/CBER, January 2021
• Recognition and Withdrawal of Voluntary Consensus Standards; Guidance for Industry and Food and Drug Administration Staff
  CDRH/CBER, 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
• Multiple Function Device Products: Policy and Considerations; Guidance for Industry and Food and Drug Administration Staff
  CDRH/CBER/OCP/CDER, 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
• Review and Update of Device Establishment Inspection Processes and Standards; Guidance for Industry
  CDRH/CBER, June 2020
• Developing and Labeling In vitro Companion Diagnostic Devices for a Specific Group or Class of Oncology Therapeutic Products; Guidance for Industry
  OCE/CBER/CDRH/CDER, April 2020
• Nonbinding Feedback After Certain FDA Inspections of Device Establishments; Guidance for Industry and Food and Drug Administration Staff
  CDRH/CBER, April 2020
• Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices; Guidance for Industry and Food and Drug Administration Staff
  CDRH/CBER, February 2020
• Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions; Guidance for Industry and Food and Drug Administration Staff
  CDRH/CBER, December 2019
• 30-Day Notices, 135-Day Premarket Approval (PMA) Supplements and 75-Day Humanitarian Device Exemption (HDE) Supplements for Manufacturing Method or Process Changes; Guidance for Industry and FDA Staff
  CDRH/CBER, December 2019
• Acceptance and Filing Reviews for Premarket Approval Applications (PMAs); Guidance for Industry and Food and Drug Administration Staff
  CDRH/CBER, December 2019
• Annual Reports for Approved Premarket Approval Applications (PMA) : Guidance for Industry and Food and Drug Administration Staff
  CDRH/CBER, December 2019
• Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act; Draft Guidance for Industry and Food and Drug Administration Staff
  CDRH/CBER, September 2019
• Policy for Device Software Functions and Mobile Medical Applications; Guidance for Industry and Food and Drug Administration Staff
  CDRH/CBER, September 2019
• Clinical Decision Support Software; Draft Guidance for Industry and Food and Drug Administration Staff
  CDRH/CBER/CDER,  September 2019
• Safety and Performance Based Pathway;Guidance for Industry and Food and Drug Administration Staff
  CDRH/CBER,  September 2019
• Refuse to Accept Policy for 510(k)s; Guidance for Industry and Food and Drug Administration Staff
  CDRH/CBER, September 2019
• The Abbreviated 510(k) Program; Guidance for Industry and Food and Drug Administration Staff
  CDRH/CBER, September 2019
• The Special 510(k) Program; Guidance for Industry and Food and Drug Administration Staff
  CDRH/CBER, September 2019
• Humanitarian Device Exemption (HDE) Program; Guidance for Industry and Food and Drug Administration Staff
  CDRH/CBER, September 2019
• 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 2019
• Male Breast Cancer: Developing Drugs for Treatment; Draft Guidance for Industry
  CDRH/CBER, August 2019
• Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications; Guidance for Industry and Food and Drug Administration Staff
  CDRH/CBER, August 2019
• Unique Device Identification: Convenience Kits; Guidance for Industry and Food and Drug Administration Staff
  CDRH/CBER, April 2019
• The Least Burdensome Provisions: Concept and Principles; Guidance for Industry and FDA Staff
  CDRH/CBER, February 2019
• User Fees and Refunds for Premarket Approval Applications and Device Biologics License Applications ; Guidance for Industry and Food and Drug Administration Staff
  CDRH/CBER, December 2018
• Manufacturing Site Change Supplements: Content and Submission ; Guidance for Industry and Food and Drug Administration Staff
  CDRH/CBER, December 2018.
• Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications (510(k)) with Different Technological Characteristics; Guidance for Industry and Food and Drug Administration Staff
  CDRH/CBER, September 2018
• Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices; Guidance for Industry and Food and Drug Administration Staff
  CDRH/CBER, September 2018
• Medical Device User Fee Small Business Qualification and Certification; Guidance for Industry, Food and Drug Administration Staff and Foreign Governments
  CDRH/CBER, August 2018 - (This document supersedes “FY 2018 Medical Device User Fee Small Business Qualification and Certification; Guidance for Industry, Food and Drug Administration Staff and Foreign Governments” dated August 29, 2017.)
• Logical Observation Identifiers Names and Codes for In Vitro Diagnostic Tests - Guidance for Industry and Food and Drug Administration Staff 
  CDRH/CBER, June 2018
• Use of Public Human Genetic Variant Databases to Support Clinical Validity for Genetic and Genomic-Based In Vitro Diagnostics; Guidance for Stakeholders and Food and Drug Administration Staff
  CDRH/CBER, April 2018
• Acceptance of Clinical Data to Support Medical Device Applications and Submissions: Frequently Asked Questions; Guidance for Industry and Food and Drug Administration Staff
  CDRH/CBER, February 2018
• Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices; Immediately in Effect Guidance for Industry and Food and Drug Administration Staff
  CDRH/CBER, January 2018
• FDA Categorization of Investigational Device Exemption (IDE) Devices to Assist the Centers for Medicare and Medicaid Services (CMS) with Coverage Decisions; Guidance for Sponsors, Clinical Investigators, Industry, Institutional Review Boards and Food and Drug Administration Staff
  CDRH/CBER, December 2017
• Medical Device Accessories - Describing Accessories and Classification Pathways; Guidance for Industry and Food and Drug Administration Staff
  CDRH/CBER, December 2017
• Technical Considerations for Additive Manufactured Medical Devices; Guidance for Industry and Food and Drug Administration Staff
  CDRH/CBER, December 2017
• Clinical and Patient Decision Support Software; Draft Guidance for Industry and Food and Drug Administration Staff
  CDRH/CBER/CDER/OCP, December 2017
• Unique Device Identification: Direct Marking of Devices; Guidance for Industry and Food and Drug Administration Staff
  CDRH/CBER, November 2017
• Deciding When to Submit a 510(k) for a Software Change to an Existing Device; Guidance for Industry and Food and Drug Administration Staff
  CDRH/CBER, October 2017
• FDA and Industry Actions on Premarket Approval Applications (PMAs): Effect on FDA Review Clock and Goals; Guidance for Industry and Food and Drug Administration Staff
  CDRH/CBER, October 2017
• FDA and Industry Actions on Premarket Notification (510(k)) Submissions: Effect on FDA Review Clock and Goals; Guidance for Industry and Food and Drug Administration Staff
  CDRH/CBER, October 2017
• User Fees for 513(g) Requests for Information; Guidance for Industry and Food and Drug Administration Staff
  CDRH/CBER, October 2017
• Evaluation and Reporting of Age-, Race-, and Ethnicity-Specific Data in Medical Device Clinical Studies; Guidance for Industry and Food and Drug Administration Staff
  CDRH/CBER, September 2017
• Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices - Guidance for Industry and Food and Drug Administration Staff
  CDRH/CBER, September 2017
• Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices - Guidance for Industry and Food and Drug Administration Staff
  CDRH/CBER, August 2017
• Factors to Consider When Making Benefit-Risk Determinations for Medical Device Investigational Device Exemptions;  Guidance for Investigational Device Exemption Sponsors, Sponsor-Investigators and Food and Drug Administration Staff
  CDRH/CBER, January 2017
• Postmarket Management of Cybersecurity in Medical Devices; Guidance for Industry and Food and Drug Administration Staff
  CDRH/CBER, December 2016
• Patient Preference Information - Voluntary Submission, Review in Premarket Approval Applications, Humanitarian Device Exemption Applications, and De Novo Requests, and Inclusion in Decision Summaries and Device Labeling - Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders
  CDRH/CBER, August 2016
• Adaptive Designs for Medical Device Clinical Studies; Guidance for Industry and Food and Drug Administration Staff
  CDRH/CBER, July 2016
• Principles for Codevelopment of an In Vitro Companion Diagnostic Device with a Therapeutic Product; Draft Guidance for Industry and Food and Drug Administration Staff
  CDRH/CDER/CBER, July 2016
• Leveraging Existing Clinical Data for Extrapolation to Pediatric Uses of Medical Devices; Guidance for Industry and Food and Drug Administration Staff
  CDRH/CBER, June 2016
• 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, December 2015 - This guidance was updated to correct addresses in Section IV.
• eCopy Program for Medical Device Submissions; Guidance for Industry and Food and Drug Administration Staff
  CDRH/CBER, December 2015
• Balancing Premarket and Postmarket Data Collection for Devices Subject to Premarket Approval - Guidance for Industry and Food and Drug Administration Staff
  CDRH/CBER, April 2015
• Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling - Guidance for Industry and Food and Drug Administration Staff
  CDRH/CBER, March 2015
• Recommendations for Labeling Medical Products to Inform Users that the Product or Product Container is not Made with Natural Rubber Latex - Guidance for Industry and Food and Drug Administration Staff
  CDRH/CDER/CBER/CVM, December 2014
• Design Considerations for Devices Intended for Home Use; Guidance for Industry and Food and Drug Administration Staff
  CDRH/CBER, November 2014
• Molecular Diagnostic Instruments with Combined Functions; Guidance for Industry and Food and Drug Administration Staff
  CDRH/CBER, November 2014
• Unique Device Identification System: Small Entity Compliance Guide; Guidance for Industry and Food and Drug Administration Staff
  CDRH/CBER, August 2014
• FDA Decisions for Investigational Device Exemption Clinical Investigations; Guidance for Sponsors, Clinical Investigators, Institutional Review Boards, and Food and Drug Administration Staff
  CDRH/CBER, August 2014
• In Vitro Companion Diagnostic Devices; Guidance for Industry and Food and Drug Administration Staff
  CDER/CBER/CDRH, August 2014
• Providing Information about Pediatric Uses of Medical Devices; Guidance for Industry and FDA Staff
  CDRH/CBER, May 2014
• Types of Communication During the Review of Medical Device Submissions; Guidance for Industry and FDA Staff
  CDRH/CBER, April 2014
• Premarket Assessment of Pediatric Medical Devices; Guidance for Industry and FDA Staff
  CDRH/CBER, March 2014
• Design Considerations for Pivotal Clinical Investigations for Medical Devices; Guidance for Industry, Clinical Investigators, Institutional Review Boards and FDA Staff
  CDRH/CBER, November 2013
• Investigational Device Exemptions (IDEs) for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human (FIH) Studies; Guidance for Industry and Food and Drug Administration Staff
  CDRH/CBER, October 2013
• Radio Frequency Wireless Technology in Medical Devices; Guidance for Industry and FDA Staff
  CDRH/CBER, August, 2013
• Technical Considerations for Pen, Jet, and Related Injectors Intended for Use with Drugs and Biological Products; Guidance for Industry and FDA Staff
  CDRH/CDER/CBER/OC, June 2013
• Assay Migration Studies for In Vitro Diagnostic Devices; Guidance for Industry and FDA Staff
  CDRH/CBER, April 2013
• Medical Device Classification Product Codes; Guidance for Industry and Food and Drug Administration Staff
  CDRH/CBER, April 2013
• Humanitarian Use Device (HUD) Designations; Guidance for Industry and FDA Staff
  CDRH/CBER/OOPD, January 2013
• In Vitro Diagnostic (IVD) Device Studies - Frequently Asked Questions; Guidance for Industry and FDA Staff
  CDRH/CBER, June 2010
• Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials
  CDRH/CBER, February 2010
• Modifications to Devices Subject to Premarket Approval (PMA) - The PMA Supplement Decision-Making Process; Guidance for Industry and FDA Staff
  CDRH/CBER, December 2008
• Indexing Structured Product Labeling
  CDER/CBER, June 2008
• Premarket Approval Application Modular Review; Guidance for Industry and FDA Staff
  CDRH/CBER, November 2003
• Quality System Information for Certain Premarket Application Reviews; Guidance for Industry and FDA Staff
  CDRH/CBER, February 2003