| Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers | 08/29/2024 |
| Electronic Submission Template for Medical Device De Novo Requests - Guidance for Industry and Food and Drug Administration Staff | 08/23/2024 |
| Laboratory Developed Tests: Small Entity Compliance Guide - Guidance for Laboratory Manufacturers and Food and Drug Administration Staff | 06/25/2024 |
| 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 | 11/17/2023 |
| 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 | 11/03/2023 |
| Enforcement Policy for Certain Supplements for Approved Premarket Approval (PMA) or Humanitarian Device Exemption (HDE) Submissions - Guidance for Industry and Food and Drug Administration Staff | 11/02/2023 |
| 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 | 09/08/2023 |
| Content of Premarket Submissions for Device Software Functions - Guidance for Industry and Food and Drug Administration Staff | 06/14/2023 |
| Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program - Guidance for Industry and Food and Drug Administration Staff | 06/02/2023 |
| 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 | 03/30/2023 |
| 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 | 11/14/2022 |
| Developing and Responding to Deficiencies in Accordance with the Least Burdensome Provisions - Guidance for Industry and Food and Drug Administration Staff | 10/26/2022 |
| Clinical Decision Support Software - Guidance for Industry and Food and Drug Administration Staff | 09/28/2022 |
| Electronic Submission Template for Medical Device 510(k) Submissions - Guidance for Industry and Food and Drug Administration Staff | 09/22/2022 |
| 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 | 07/25/2022 |
| 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 | 01/26/2022 |
| Patient Engagement in the Design and Conduct of Medical Device Clinical Studies - Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders | 01/26/2022 |
| 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 | 10/05/2021 |
| De Novo Classification Process (Evaluation of Automatic Class III Designation) - Guidance for Industry and Food and Drug Administration Staff | 10/05/2021 |
| User Fees and Refunds for De Novo Classification Requests - Guidance for Industry and Food and Drug Administration Staff | 10/05/2021 |
| Acceptance Review for De Novo Classification Requests - Guidance for Industry and Food and Drug Administration Staff | 10/05/2021 |
| Safer Technologies Program for Medical Devices - Guidance for Industry and Food and Drug Administration Staff | 01/06/2021 |
| The Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program - Guidance for Industry, Accreditation Bodies, Testing Laboratories, and Food and Drug Administration Staff | 09/25/2020 |
| 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 | 09/25/2020 |
| 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 | 09/25/2020 |
| Multiple Function Device Products: Policy and Considerations - Guidance for Industry and Food and Drug Administration Staff | 07/29/2020 |
| Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use - Guidance for Industry and Food and Drug Administration Staff | 07/21/2020 |
| Providing Regulatory Submissions for Medical Devices in Electronic Format - Submissions Under Section 745A(b) of the Federal Food, Drug, and Cosmetic Act - Guidance for Industry and Food and Drug Administration Staff | 07/15/2020 |
| Nonbinding Feedback After Certain FDA Inspections of Device Establishments - Guidance for Industry and Food and Drug Administration Staff | 04/22/2020 |
| Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act - Guidance for Industry and Food and Drug Administration Staff | 09/27/2019 |
| Policy for Device Software Functions and Mobile Medical Applications - Guidance for Industry and Food and Drug Administration Staff | 09/27/2019 |
| Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices - Guidance for Industry and Food and Drug Administration Staff | 09/27/2019 |
| The Special 510(k) Program - Guidance for Industry and Food and Drug Administration Staff | 09/13/2019 |
| Format for Traditional and Abbreviated 510(k)s - Guidance for Industry and FDA Staff | 09/13/2019 |
| The Abbreviated 510(k) Program - Guidance for Industry and Food and Drug Administration Staff | 09/13/2019 |
| Refuse to Accept Policy for 510(k)s - Guidance for Industry and Food and Drug Administration Staff | 09/13/2019 |
| Humanitarian Device Exemption (HDE) Program - Guidance for Industry and Food and Drug Administration Staff | 09/05/2019 |
| 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 | 08/30/2019 |
| Testing for Biotin Interference in In Vitro Diagnostic Devices - Draft Guidance for Industry | 06/13/2019 |
| Unique Device Identification: Convenience Kits - Guidance for Industry and Food and Drug Administration Staff | 04/26/2019 |
| Evaluation of Devices Used with Regenerative Medicine Advanced Therapies - Guidance for Industry (PDF - 193KB) | 02/15/2019 |
| The Least Burdensome Provisions: Concept and Principles - Guidance for Industry and FDA Staff (PDF - 484KB) | 02/05/2019 |
| Safety and Performance Based Pathway - Guidance for Industry and Food and Drug Administration (PDF - 121KB) | 01/22/2019 |
| Developing and Labeling In vitro Companion Diagnostic Devices for a Specific Group or Class of Oncology Therapeutic Products | 12/06/2018 |
| 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 (PDF - 538KB) | 09/25/2018 |
| Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff (PDF - 364KB) | 09/14/2018 |
| Medical Device User Fee Small Business Qualification and Certification - Guidance for Industry, Food and Drug Administration Staff and Foreign Governments (PDF - 208KB) | 08/01/2018 |
| Logical Observation Identifiers Names and Codes for In Vitro Diagnostic Tests - Guidance for Industry and Food and Drug Administration Staff (PDF - 323KB) | 06/15/2018 |
| Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities - Questions and Answers Guidance for Industry and Review Staff (PDF - 524KB) | 06/12/2018 |
| Acceptance of Clinical Data to Support Medical Device Applications and Submissions: Frequently Asked Questions - Guidance for Industry and Food and Drug Administration Staff (PDF - 485KB) | 02/21/2018 |
| Guidance for Industry and Food and Drug Administration Staff - Acceptance and Filing Review for Premarket Approval Applications (PMAs) (PDF - 551KB) | 01/30/2018 |
| Medical Device Accessories - Describing Accessories and Classification Pathways - Guidance for Industry and FDA Staff (PDF - 449KB) | 12/20/2017 |
| Technical Considerations for Additive Manufactured Medical Devices - Guidance for Industry and Food and Drug Administration Staff (PDF - 803KB) | 12/05/2017 |
| 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 (PDF - 573KB) | 12/05/2017 |
| Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use; Guidance for Industry and Food and Drug Administration Staff (PDF - 198KB) | 12/12/2017 |
| Unique Device Identification: Direct Marking of Devices - Guidance for Industry and Food and Drug Administration Staff (PDF - 587KB) | 11/17/2017 |
| Deciding When to Submit a 510(k) for a Software Change to an Existing Device - Guidance for Industry and Food and Drug Administration Staff (PDF - 585KB) | 10/25/2017 |
| Deciding When to Submit a 510(k) for a Change to an Existing Device - Guidance for Industry and Food and Drug Administration Staff (PDF - 1MB) | 10/25/2017 |
| User Fees and Refunds for Premarket Approval Applications and Device Biologics License Applications - Guidance for Industry and Food and Drug Administration Staff (PDF - 513KB) | 10/02/2017 |
| User Fees and Refunds for Premarket Notification Submissions (510(k)s) - Guidance for Industry and Food and Drug Administration Staff (PDF - 118KB) | 10/02/2017 |
| User Fees for 513(g) Requests for Information - Guidance for Industry and Food and Drug Administration Staff (PDF - 83KB) | 10/02/2017 |
| 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 (PDF - 485KB) | 10/02/2017 |
| 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 (PDF - 594KB) | 10/02/2017 |
| Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff - Guidance for Industry and Food and Drug Administration Staff (PDF - 423KB) | 10/02/2017 |
| Evaluation and Reporting of Age-, Race-, and Ethnicity-Specific Data in Medical Device Clinical Studies - Guidance for Industry and Food and Drug Administration Staff (PDF - 1.1MB) | 09/12/2017 |
| Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices - Guidance for Industry and Food and Drug Administration Staff (PDF - 421KB) | 09/06/2017 |
| Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices - Guidance for Industry and Food and Drug Administration Staff (PDF - 537KB) | 08/31/2017 |
| Postmarket Management of Cybersecurity in Medical Devices - Guidance for Industry and Food and Drug Administration Staff (PDF - 1.2MB) | 12/28/2016 |
| 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 (PDF - 766KB) | 08/24/2016 |
| Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications - Guidance for Industry and FDA Staff (PDF - 1.1MB) | 08/24/2016 |
| Adaptive Designs for Medical Device Clinical Studies - Guidance for Industry and Food and Drug Administration Staff (PDF - 587KB) | 07/27/2016 |
| Leveraging Existing Clinical Data for Extrapolation to Pediatric Uses of Medical Devices - Guidance for Industry and Food and Drug Administration Staff (PDF - 367KB) | 06/21/2016 |
| 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 (PDF - 386KB) | 01/21/2016 |
| eCopy Program for Medical Device Submissions - Guidance for Industry and Food and Drug Administration Staff (PDF - 525KB) | 12/03/2015 |
| Balancing Premarket and Postmarket Data Collection for Devices Subject to Premarket Approval - Guidance for Industry and Food and Drug Administration Staff (PDF - 500KB) | 04/13/2015 |
| Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling - Guidance for Industry and Food and Drug Administration Staff (PDF - 805KB) | 03/17/2015 |
| 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 (PDF - 76KB) | 12/02/2014 |
| Design Considerations for Devices Intended for Home Use - Guidance for Industry and Food and Drug Administration Staff (PDF - 523KB) | 11/24/2014 |
| Molecular Diagnostic Instruments with Combined Functions - Guidance for Industry and Food and Drug Administration Staff (PDF - 425KB) | 11/12/2014 |
| Content of Premarket Submissions for Management of Cybersecurity in Medical Devices - Guidance for Industry and Food and Drug Administration Staff (PDF - 324KB) | 10/02/2014 |
| Evaluation of Sex-Specific Data in Medical Device Clinical Studies - Guidance for Industry and Food and Drug Administration Staff (PDF - 941KB) | 08/22/2014 |
| Unique Device Identifier System: Frequently Asked Questions, Vol. 1 - Guidance for Industry and Food and Drug Administration Staff (PDF - 462KB) | 08/20/2014 |
| FDA Decisions for Investigational Device Exemption Clinical Investigations - Guidance for Sponsors, Clinical Investigators, Institutional Review Boards, and Food and Drug Administration Staff (PDF - 631KB) | 08/19/2014 |
| Unique Device Identification System: Small Entity Compliance Guide - Guidance for Industry and Food and Drug Administration Staff (PDF - 420KB) | 08/13/2014 |
| In Vitro Companion Diagnostic Devices - Guidance for Industry and Food and Drug Administration Staff (PDF - 159KB) | 08/06/2014 |
| The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)] - Guidance for Industry and Food and Drug Administration Staff (PDF - 844KB) | 07/28/2014 |
| Global Unique Device Identification Database (GUDID) - Guidance for Industry and Food and Drug Administration Staff | 12/17/2024 |
| Providing Information about Pediatric Uses of Medical Devices - Guidance for Industry and FDA Staff (PDF - 177KB) | 05/01/2014 |
| Types of Communication During the Review of Medical Device Submissions - Guidance for Industry and FDA Staff (PDF - 134KB) | 04/04/2014 |
| Premarket Assessment of Pediatric Medical Devices - Guidance for Industry and FDA Staff (PDF - 162KB) | 03/24/2014 |
| Annual Reports for Approved Premarket Approval Applications (PMA) - Guidance for Industry and Food and Drug Administration Staff (PDF - 95KB) | 02/10/2014 |
| Design Considerations for Pivotal Clinical Investigations for Medical Devices - Guidance for Industry, Clinical Investigators, Institutional Review Boards and FDA Staff (PDF - 402KB) | 11/07/2013 |
| 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 (PDF - 1.3MB) | 10/01/2013 |
| IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites, and the Determination of Whether an IND/IDE is Needed | 08/27/2013 |
| Radio Frequency Wireless Technology in Medical Devices - Guidance for Industry and FDA Staff (PDF - 139KB) | 08/14/2013 |
| Guidance for Industry: Oversight of Clinical Investigations - Risk-Based Approach to Monitoring (PDF - 163KB) | 08/06/2013 |
| Heparin for Drug and Medical Device Use: Monitoring Crude Heparin for Quality (PDF - 60KB) | 06/25/2013 |
| Assay Migration Studies for In Vitro Diagnostic Devices - Guidance for Industry and FDA Staff (PDF - 1.2MB) | 04/25/2013 |
| Medical Device Classification Product Codes - Guidance for Industry and Food and Drug Administration Staff | 04/11/2013 |
| Financial Disclosure by Clinical Investigators (PDF - 165KB) | 02/01/2013 |
| Humanitarian Use Device (HUD) Designations - Guidance for Industry and FDA Staff (PDF - 141KB) | 01/24/2013 |
| IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites, and the Determination of Whether an IND/IDE is Needed (Printer-Friendly) (PDF - 47KB) | 08/27/2013 |
| 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 (PDF - 358KB) | 04/06/2012 |
| Guidance for Industry: Preparation of IDEs and INDs for Products Intended to Repair or Replace Knee Cartilage (PDF - 157KB) | 12/01/2011 |
| Distribution of In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only - Guidance for Industry and FDA Staff (PDF - 195KB) | 11/25/2013 |
| 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 (PDF - 80KB) | 04/13/2011 |
| Guidance for Industry and FDA Staff: In Vitro Diagnostic (IVD) Device Studies - Frequently Asked Questions (PDF - 352KB) | 06/25/2010 |
| Modifications to Devices Subject to Premarket Approval (PMA) - The PMA Supplement Decision-Making Process - Guidance for Industry and FDA Staff (PDF - 200KB) | 12/11/2008 |
| Bundling Multiple Devices or Multiple Indications in a Single Submission - Guidance for Industry and FDA Staff (PDF - 439KB) | 06/22/2007 |
| Pharmacogenetic Tests and Genetic Tests for Heritable Markers - Guidance for Industry and FDA Staff (PDF - 66KB) | 02/09/2006 |
| Real-Time Premarket Approval Application (PMA) Supplements - Guidance for Industry and FDA Staff (PDF - 82KB) | 04/28/2006 |
| Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable - Guidance for Sponsors, Institutional Review Boards, and Food and Drug Administration Staff (PDF - 369KB) | 04/25/2006 |
| Significant Risk and Nonsignificant Risk Medical Device Studies - Information Sheet (PDF - 211KB) | 01/01/2006 |
| Premarket Approval Application Modular Review - Guidance for Industry and FDA Staff (PDF - 213KB) | 11/03/2003 |
| General Principles of Software Validation - Final Guidance for Industry and FDA Staff (PDF - 367KB) | 01/11/2002 |
