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                Guidance Documents (Medical Devices and Radiation-Emitting Products)

Guidance Documents (Medical Devices and Radiation-Emitting Products)

                        Cross-Center Final Guidance
          Recent Final Medical Device Guidance Documents
          Draft Medical Device Guidance
          CDRH Proposed Guidance Development
          Class II Special Controls Documents
          Withdrawn or Expired Guidance
          Tips for Submitting Comments on CDRH Guidance Documents Home
          Medical Devices
          Device Advice: Comprehensive Regulatory Assistance
          Guidance Documents (Medical Devices and Radiation-Emitting Products)
          Cross-Center Final GuidanceGuidance Documents (Medical Devices and Radiation-Emitting Products) Cross-Center Final Guidance
  
  	
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    PrintThis page lists final guidance documents developed by CDRH and other FDA Centers. For a list of current draft guidance documents, please see the Draft Guidance page.

Some Web links (URLs) embedded within guidance documents are no longer valid. If you find a link that does not work, please try searching for the document using the document title.

Cross-Center Final Guidance Documents

Title
			Issued DateNotifying 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
			11/17/23Process 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
			11/03/23Enforcement Policy for Certain Supplements for Approved Premarket Approval (PMA) or Humanitarian Device Exemption (HDE) Submissions - Guidance for Industry and Food and Drug Administration Staff
			11/02/23Use 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
			09/08/23Content of Premarket Submissions for Device Software Functions - Guidance for Industry and Food and Drug Administration Staff
			06/14/23Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program - Guidance for Industry and Food and Drug Administration Staff
			06/02/23Cybersecurity 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
			03/30/23Referencing 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
			11/14/22Developing and Responding to Deficiencies in Accordance with the Least Burdensome Provisions - Guidance for Industry and Food and Drug Administration Staff
			10/26/22Clinical Decision Support Software - Guidance for Industry and Food and Drug Administration Staff
			09/28/22Electronic Submission Template for Medical Device 510(k) Submissions - Guidance for Industry and Food and Drug Administration Staff
			09/22/22Unique 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
			07/25/22Principles 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
			01/26/22Patient Engagement in the Design and Conduct of Medical Device Clinical Studies - Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders
			01/26/22FDA and Industry Actions on De Novo Classification Requests: Effect on FDA Review Clock and Goals - Guidance for Industry and Food and Drug Administration Staff
			10/05/21De Novo Classification Process (Evaluation of Automatic Class III Designation) - Guidance for Industry and Food and Drug Administration Staff
			10/05/21User Fees and Refunds for De Novo Classification Requests - Guidance for Industry and Food and Drug Administration Staff
			10/05/21Acceptance Review for De Novo Classification Requests - Guidance for Industry and Food and Drug Administration Staff
			10/05/21Safer Technologies Program for Medical Devices - Guidance for Industry and Food and Drug Administration Staff
			01/06/21The Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program - Guidance for Industry, Accreditation Bodies, Testing Laboratories, and Food and Drug Administration Staff
			09/25/20Basic 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
			09/25/20Biocompatibility 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
			09/25/20Multiple Function Device Products: Policy and Considerations - Guidance for Industry and Food and Drug Administration Staff
			07/29/20Regulatory 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
			07/21/20Providing 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
			07/15/20Nonbinding Feedback After Certain FDA Inspections of Device Establishments - Guidance for Industry and Food and Drug Administration Staff
			04/22/20Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act - Guidance for Industry and Food and Drug Administration Staff
			09/27/19Policy for Device Software Functions and Mobile Medical Applications - Guidance for Industry and Food and Drug Administration Staff
			09/27/19Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices - Guidance for Industry and Food and Drug Administration Staff
			09/27/19The Special 510(k) Program - Guidance for Industry and Food and Drug Administration Staff
			09/13/19Format for Traditional and Abbreviated 510(k)s - Guidance for Industry and FDA Staff
			09/13/19The Abbreviated 510(k) Program - Guidance for Industry and Food and Drug Administration Staff
			09/13/19Refuse to Accept Policy for 510(k)s - Guidance for Industry and Food and Drug Administration Staff
			09/13/19Humanitarian Device Exemption (HDE) Program - Guidance for Industry and Food and Drug Administration Staff
			09/05/19Factors 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
			08/30/19Testing for Biotin Interference in In Vitro Diagnostic Devices - Draft Guidance for Industry
			06/13/19Unique Device Identification: Convenience Kits - Guidance for Industry and Food and Drug Administration Staff
			04/26/19Evaluation of Devices Used with Regenerative Medicine Advanced Therapies - Guidance for Industry (PDF - 193KB)
			02/15/19The Least Burdensome Provisions: Concept and Principles - Guidance for Industry and FDA Staff (PDF - 484KB)
			02/05/19Safety and Performance Based Pathway - Guidance for Industry and Food and Drug Administration (PDF - 121KB)
			01/22/19Developing and Labeling In vitro Companion Diagnostic Devices for a Specific Group or Class of Oncology Therapeutic Products
			12/06/18Benefit-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)
			09/25/18Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff (PDF - 364KB)
			09/14/18Medical Device User Fee Small Business Qualification and Certification - Guidance for Industry, Food and Drug Administration Staff and Foreign Governments (PDF - 208KB)
			08/01/18Logical Observation Identifiers Names and Codes for In Vitro Diagnostic Tests - Guidance for Industry and Food and Drug Administration Staff (PDF - 323KB)
			06/15/18Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities - Questions and Answers Guidance for Industry and Review Staff (PDF - 524KB)
			06/12/18Acceptance of Clinical Data to Support Medical Device Applications and Submissions: Frequently Asked Questions - Guidance for Industry and Food and Drug Administration Staff (PDF - 485KB)
			02/21/18Guidance for Industry and Food and Drug Administration Staff - Acceptance and Filing Review for Premarket Approval Applications (PMAs) (PDF - 551KB)
			01/30/18Medical Device Accessories - Describing Accessories and Classification Pathways - Guidance for Industry and FDA Staff (PDF - 449KB)
			12/20/17Technical Considerations for Additive Manufactured Medical Devices - Guidance for Industry and Food and Drug Administration Staff (PDF - 803KB)
			12/05/17FDA 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)
			12/05/17Regulatory 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)
			12/12/17Unique Device Identification: Direct Marking of Devices - Guidance for Industry and Food and Drug Administration Staff (PDF - 587KB)
			11/17/17Deciding 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)
			10/25/17Deciding When to Submit a 510(k) for a Change to an Existing Device - Guidance for Industry and Food and Drug Administration Staff (PDF - 1MB)
			10/25/17User Fees and Refunds for Premarket Approval Applications and Device Biologics License Applications - Guidance for Industry and Food and Drug Administration Staff (PDF - 513KB)
			10/02/17User Fees and Refunds for Premarket Notification Submissions (510(k)s) - Guidance for Industry and Food and Drug Administration Staff (PDF - 118KB)
			10/02/17User Fees for 513(g) Requests for Information - Guidance for Industry and Food and Drug Administration Staff (PDF - 83KB)
			10/02/17FDA 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)
			10/02/17FDA 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)
			10/02/17Requests 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)
			10/02/17Evaluation 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)
			09/12/17Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices - Guidance for Industry and Food and Drug Administration Staff (PDF - 421KB)
			09/06/17Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices - Guidance for Industry and Food and Drug Administration Staff (PDF - 537KB)
			08/31/17Postmarket Management of Cybersecurity in Medical Devices - Guidance for Industry and Food and Drug Administration Staff (PDF - 1.2MB)
			12/28/16Patient 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)
			08/24/16Factors 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)
			08/24/16Adaptive Designs for Medical Device Clinical Studies - Guidance for Industry and Food and Drug Administration Staff (PDF - 587KB)
			07/27/16Leveraging Existing Clinical Data for Extrapolation to Pediatric Uses of Medical Devices - Guidance for Industry and Food and Drug Administration Staff (PDF - 367KB)
			06/21/16Submission 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)
			01/21/16eCopy Program for Medical Device Submissions - Guidance for Industry and Food and Drug Administration Staff (PDF - 525KB)
			12/03/15Balancing Premarket and Postmarket Data Collection for Devices Subject to Premarket Approval - Guidance for Industry and Food and Drug Administration Staff (PDF - 500KB)
			04/13/15Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling - Guidance for Industry and Food and Drug Administration Staff (PDF - 805KB)
			03/17/15Recommendations 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)
			12/02/14Design Considerations for Devices Intended for Home Use - Guidance for Industry and Food and Drug Administration Staff (PDF - 523KB)
			11/24/14Molecular Diagnostic Instruments with Combined Functions - Guidance for Industry and Food and Drug Administration Staff (PDF - 425KB)
			11/12/14Content of Premarket Submissions for Management of Cybersecurity in Medical Devices - Guidance for Industry and Food and Drug Administration Staff (PDF - 324KB)
			10/02/14Evaluation of Sex-Specific Data in Medical Device Clinical Studies - Guidance for Industry and Food and Drug Administration Staff (PDF - 941KB)
			08/22/14Unique Device Identifier System: Frequently Asked Questions, Vol. 1 - Guidance for Industry and Food and Drug Administration Staff (PDF - 462KB)
			08/20/14FDA Decisions for Investigational Device Exemption Clinical Investigations - Guidance for Sponsors, Clinical Investigators, Institutional Review Boards, and Food and Drug Administration Staff (PDF - 631KB)
			08/19/14Unique Device Identification System: Small Entity Compliance Guide - Guidance for Industry and Food and Drug Administration Staff (PDF - 420KB)
			08/13/14In Vitro Companion Diagnostic Devices - Guidance for Industry and Food and Drug Administration Staff (PDF - 159KB)
			08/06/14The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)] - Guidance for Industry and Food and Drug Administration Staff (PDF - 844KB)
			07/28/14Global Unique Device Identification Database (GUDID) - Guidance for Industry and Food and Drug Administration Staff (PDF - 2.8MB)
			06/27/14Providing Information about Pediatric Uses of Medical Devices - Guidance for Industry and FDA Staff (PDF - 177KB)
			05/01/14Types of Communication During the Review of Medical Device Submissions - Guidance for Industry and FDA Staff (PDF - 134KB)
			04/04/14Premarket Assessment of Pediatric Medical Devices - Guidance for Industry and FDA Staff (PDF - 162KB)
			03/24/14Annual Reports for Approved Premarket Approval Applications (PMA) - Guidance for Industry and Food and Drug Administration Staff (PDF - 95KB)
			02/10/14Design Considerations for Pivotal Clinical Investigations for Medical Devices - Guidance for Industry, Clinical Investigators, Institutional Review Boards and FDA Staff (PDF - 402KB)
			11/07/13Investigational 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)
			10/01/13IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites, and the Determination of Whether an IND/IDE is Needed
			08/27/13Radio Frequency Wireless Technology in Medical Devices - Guidance for Industry and FDA Staff (PDF - 139KB)
			08/14/13Guidance for Industry: Oversight of Clinical Investigations - Risk-Based Approach to Monitoring (PDF - 163KB)
			08/06/13Heparin for Drug and Medical Device Use: Monitoring Crude Heparin for Quality (PDF - 60KB)
			06/25/13Assay Migration Studies for In Vitro Diagnostic Devices - Guidance for Industry and FDA Staff (PDF - 1.2MB)
			04/25/13Medical Device Classification Product Codes - Guidance for Industry and Food and Drug Administration Staff
			04/11/13Financial Disclosure by Clinical Investigators (PDF - 165KB)
			02/01/13Humanitarian Use Device (HUD) Designations - Guidance for Industry and FDA Staff (PDF - 141KB)
			01/24/13IRB 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)
			08/27/13FDA 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)
			04/06/12Guidance for Industry: Preparation of IDEs and INDs for Products Intended to Repair or Replace Knee Cartilage (PDF - 157KB)
			12/01/11Distribution of In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only - Guidance for Industry and FDA Staff (PDF - 195KB)
			11/25/1330-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)
			04/13/11Guidance for Industry and FDA Staff: In Vitro Diagnostic (IVD) Device Studies - Frequently Asked Questions (PDF - 352KB)
			06/25/10Modifications to Devices Subject to Premarket Approval (PMA) - The PMA Supplement Decision-Making Process - Guidance for Industry and FDA Staff (PDF - 200KB)
			12/11/08Bundling Multiple Devices or Multiple Indications in a Single Submission - Guidance for Industry and FDA Staff (PDF - 439KB)
			06/22/07Pharmacogenetic Tests and Genetic Tests for Heritable Markers - Guidance for Industry and FDA Staff (PDF - 66KB)
			02/09/06Real-Time Premarket Approval Application (PMA) Supplements - Guidance for Industry and FDA Staff (PDF - 82KB)
			04/28/06Guidance 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)
			04/25/06Significant Risk and Nonsignificant Risk Medical Device Studies - Information Sheet (PDF - 211KB)
			01/01/06Premarket Approval Application Modular Review - Guidance for Industry and FDA Staff (PDF - 213KB)
			11/03/03General Principles of Software Validation - Final Guidance for Industry and FDA Staff (PDF - 367KB)
			01/11/02

                                                                                  Content current as of:
      11/28/2023
              
              
Regulated Product(s)
		 Medical Devices
			  			     			  			     Radiation-Emitting ProductsGuidance Documents (Medical Devices and Radiation-Emitting Products)

          
                        Cross-Center Final Guidance
          Recent Final Medical Device Guidance Documents
          Draft Medical Device Guidance
          CDRH Proposed Guidance Development
          Class II Special Controls Documents
          Withdrawn or Expired Guidance
          Tips for Submitting Comments on CDRH Guidance Documents
 
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