Devices Guidances
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Select Updates for the Medical Device User Fee Small Business Qualification and Certification Guidance; Draft Guidance for Industry and Food and Drug Administration Staff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 -
Electronic Submission Template for Medical Device De Novo Requests; Draft Guidance for Industry and Food and Drug Administration Staff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Best Practices for Selecting a Predicate Device to Support a Premarket Notification [510(k)] Submission; Draft Guidance for Industry and Food and Drug Administration Staff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Recommendations for the Use of Clinical Data in Premarket Notification [510(k)] Submissions; Draft Guidance for Industry and Food and Drug Administration Staff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Evidentiary Expectations for 510(k) Implant Devices; Draft Guidance for Industry and Food and Drug Administration Staff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 -
Cybersecurity in Medical Devices: Refuse to Accept Policy for Cyber Devices and Related Systems Under Section 524B of the FD&C Act; Guidance for Industry and Food and Drug Administration Staff
CDRH/CBER, March 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 -
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 -
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 -
Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act; Draft Guidance for Industry and Food and Drug Administration Staff
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 -
Remanufacturing of Medical Devices; Draft Guidance for Industry and Food and Drug Administration Staff
CDRH/CBER, June 2021 -
Safer Technologies Program for Medical Devices; Guidance for Industry and Food and Drug Administration Staff
CDRH/CBER, January 2021 -
Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program; Guidance for Industry and Food and Drug Administration Staff
CDRH/CBER, January 2021 -
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 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 -
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 -
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 -
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 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 -
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, 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 -
Multiple Function Device Products: Policy and Considerations; Draft Guidance for Industry and Food and Drug Administration
CDRH/CBER, April 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 -
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 -
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 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
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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