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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Predetermined Change Control Plans for Medical Devices; Draft Guidance for Industry and Food and Drug Administration Staff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Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program; Draft Guidance for Industry and Food and Drug Administration Staff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Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the FD&C Act; Draft Guidance for Industry and Food and Drug Administration Staff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Select Updates for the Medical Device User Fee Small Business Qualification and Certification Guidance; Draft Guidance for Industry and Food and Drug Administration Staff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
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
Electromagnetic Compatibility (EMC) of Medical Devices; Guidance for Industry and Food and Drug Administration Staff
CDRH/CBER, June 2022
Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions; Draft Guidance for Industry and Food and Drug Administration Staff
CDRH/CBER, April 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
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
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
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
Format for Traditional and Abbreviated 510(k)s; 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
Review and Update of Device Establishment Inspection Processes and Standards; Draft Guidance for Industry
ORA/CDRH/CBER, March 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
Recognition and Withdrawal of Voluntary Consensus Standards; Draft 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
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
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
Postmarket Management of Cybersecurity in Medical Devices; Guidance for Industry and Food and Drug Administration Staff
CDRH/CBER, December 2016
Enforcement Policy on National Health Related Item Code and National Drug Code Numbers Assigned to Devices – Guidance for Industry and Food and Drug Administration Staff
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
Global Unique Device Identification Database (GUDID): Data Submission Compliance Date of September 24, 2015; Guidance for Industry and Food and Drug Administration Staff
CDRH/CBER, August 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
CDRH/CBER, October 2014
Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs); Draft Guidance for Industry, Food and Drug Administration Staff, and Clinical Laboratories
CDRH/CBER, September 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
Global Unique Device Identification Database (GUDID); Draft Guidance for Industry
CDRH/CBER, June 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
