| 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) |
09/25/18 |
| Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff (PDF - 364KB) |
09/14/18 |
| Medical Device User Fee Small Business Qualification and Certification - Guidance for Industry, Food and Drug Administration Staff and Foreign Governments (PDF - 208KB) |
08/01/18 |
| Logical Observation Identifiers Names and Codes for In Vitro Diagnostic Tests - Guidance for Industry and Food and Drug Administration Staff (PDF - 323KB) |
06/15/18 |
| Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities - Questions and Answers Guidance for Industry and Review Staff (PDF - 524KB) |
06/12/18 |
| 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) |
02/21/18 |
| Guidance for Industry and Food and Drug Administration Staff - Acceptance and Filing Review for Premarket Approval Applications (PMAs) (PDF - 551KB) |
01/30/18 |
| Guidance for Industry and Food and Drug Administration Staff - Refuse to Accept Policy for 510(k)s (PDF - 1.9MB) |
01/30/18 |
| 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 (PDF - 93KB) |
01/16/18 |
| Medical Device Accessories - Describing Accessories and Classification Pathways - Guidance for Industry and FDA Staff (PDF - 449KB) |
12/20/17 |
| Technical Considerations for Additive Manufactured Medical Devices - Guidance for Industry and Food and Drug Administration Staff (PDF - 803KB) |
12/05/17 |
| 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) |
12/05/17 |
| 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) |
12/12/17 |
| Unique Device Identification: Direct Marking of Devices - Guidance for Industry and Food and Drug Administration Staff (PDF - 587KB) |
11/17/17 |
| De Novo Classification Process (Evaluation of Automatic Class III Designation) - Guidance for Industry and Food and Drug Administration Staff (PDF - 139KB) |
10/30/17 |
| 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) |
10/25/17 |
| 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) |
10/25/17 |
| User Fees and Refunds for Premarket Approval Applications and Device Biologics License Applications - Guidance for Industry and Food and Drug Administration Staff (PDF - 513KB) |
10/02/17 |
| User Fees and Refunds for Premarket Notification Submissions (510(k)s) - Guidance for Industry and Food and Drug Administration Staff (PDF - 118KB) |
10/02/17 |
| User Fees for 513(g) Requests for Information - Guidance for Industry and Food and Drug Administration Staff (PDF - 83KB) |
10/02/17 |
| User Fees and Refunds for De Novo Classification Requests - Guidance for Industry and Food and Drug Administration Staff (PDF - 419KB) |
10/02/17 |
| 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 (PDF - 396KB) |
10/02/17 |
| 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) |
10/02/17 |
| 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) |
10/02/17 |
| 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) |
10/02/17 |
| Developing and Responding to Deficiencies in Accordance with the Least Burdensome Provisions - Guidance for Industry and Food and Drug Administration Staff (PDF - 440KB) |
09/29/17 |
| 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) |
09/12/17 |
| Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices - Guidance for Industry and Food and Drug Administration Staff (PDF - 421KB) |
09/06/17 |
| Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices - Guidance for Industry and Food and Drug Administration Staff (PDF - 537KB) |
08/31/17 |
| 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 (PDF - 749KB) |
01/13/17 |
| Postmarket Management of Cybersecurity in Medical Devices - Guidance for Industry and Food and Drug Administration Staff (PDF - 1.2MB) |
12/28/16 |
| 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 (PDF - 286KB) |
08/30/16 |
| 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) |
08/24/16 |
| 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) |
08/24/16 |
| Adaptive Designs for Medical Device Clinical Studies - Guidance for Industry and Food and Drug Administration Staff (PDF - 587KB) |
07/27/16 |
| Leveraging Existing Clinical Data for Extrapolation to Pediatric Uses of Medical Devices - Guidance for Industry and Food and Drug Administration Staff (PDF - 367KB) |
06/21/16 |
| 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) |
01/21/16 |
| eCopy Program for Medical Device Submissions - Guidance for Industry and Food and Drug Administration Staff (PDF - 525KB) |
12/03/15 |
| Global Unique Device Identification Database (GUDID): Data Submission Compliance Date of September 24, 2015 - Guidance for Industry and FDA Staff (PDF - 199KB) |
08/14/15 |
| Balancing Premarket and Postmarket Data Collection for Devices Subject to Premarket Approval - Guidance for Industry and Food and Drug Administration Staff (PDF - 500KB) |
04/13/15 |
| Expedited Access for Premarket Approval and De Novo Medical Devices Intended for Unmet Medical Need for Life Threatening or Irreversibly Debilitating Diseases or Conditions - Guidance for Industry and Food and Drug Administration Staff (PDF - 840KB) |
04/13/15 |
| Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling - Guidance for Industry and Food and Drug Administration Staff (PDF - 805KB) |
03/17/15 |
| Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices - Guidance for Industry and Food and Drug Administration Staff (PDF - 650KB) |
02/09/15 |
| Mobile Medical Applications - Guidance for Industry and Food and Drug Administration Staff (PDF - 1.3MB) |
02/09/15 |
| 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) |
12/02/14 |
| Design Considerations for Devices Intended for Home Use - Guidance for Industry and Food and Drug Administration Staff (PDF - 523KB) |
11/24/14 |
| Molecular Diagnostic Instruments with Combined Functions - Guidance for Industry and Food and Drug Administration Staff (PDF - 425KB) |
11/12/14 |
| Content of Premarket Submissions for Management of Cybersecurity in Medical Devices - Guidance for Industry and Food and Drug Administration Staff (PDF - 324KB) |
10/02/14 |
| Evaluation of Sex-Specific Data in Medical Device Clinical Studies - Guidance for Industry and Food and Drug Administration Staff (PDF - 941KB) |
08/22/14 |
| Unique Device Identifier System: Frequently Asked Questions, Vol. 1 - Guidance for Industry and Food and Drug Administration Staff (PDF - 462KB) |
08/20/14 |
| FDA Decisions for Investigational Device Exemption Clinical Investigations - Guidance for Sponsors, Clinical Investigators, Institutional Review Boards, and Food and Drug Administration Staff (PDF - 631KB) |
08/19/14 |
| Unique Device Identification System: Small Entity Compliance Guide - Guidance for Industry and Food and Drug Administration Staff (PDF - 420KB) |
08/13/14 |
| In Vitro Companion Diagnostic Devices - Guidance for Industry and Food and Drug Administration Staff (PDF - 159KB) |
08/06/14 |
| The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)] - Guidance for Industry and Food and Drug Administration Staff (PDF - 844KB) |
07/28/14 |
| Global Unique Device Identification Database (GUDID) - Guidance for Industry and Food and Drug Administration Staff (PDF - 2.8MB) |
06/27/14 |
| Providing Information about Pediatric Uses of Medical Devices - Guidance for Industry and FDA Staff (PDF - 177KB) |
05/01/14 |
| Types of Communication During the Review of Medical Device Submissions - Guidance for Industry and FDA Staff (PDF - 134KB) |
04/04/14 |
| Premarket Assessment of Pediatric Medical Devices - Guidance for Industry and FDA Staff (PDF - 162KB) |
03/24/14 |
| Annual Reports for Approved Premarket Approval Applications (PMA) - Guidance for Industry and Food and Drug Administration Staff (PDF - 95KB) |
02/10/14 |
| Design Considerations for Pivotal Clinical Investigations for Medical Devices - Guidance for Industry, Clinical Investigators, Institutional Review Boards and FDA Staff (PDF - 402KB) |
11/07/13 |
| 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) |
10/01/13 |
| IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites, and the Determination of Whether an IND/IDE is Needed |
08/27/13 |
| Radio Frequency Wireless Technology in Medical Devices - Guidance for Industry and FDA Staff (PDF - 139KB) |
08/14/13 |
| Guidance for Industry: Oversight of Clinical Investigations - Risk-Based Approach to Monitoring (PDF - 163KB) |
08/06/13 |
| Heparin for Drug and Medical Device Use: Monitoring Crude Heparin for Quality (PDF - 60KB) |
06/25/13 |
| Assay Migration Studies for In Vitro Diagnostic Devices - Guidance for Industry and FDA Staff (PDF - 1.2MB) |
04/25/13 |
| Medical Device Classification Product Codes - Guidance for Industry and Food and Drug Administration Staff |
04/11/13 |
| Financial Disclosure by Clinical Investigators (PDF - 165KB) |
02/01/13 |
| Humanitarian Use Device (HUD) Designations - Guidance for Industry and FDA Staff (PDF - 141KB) |
01/24/13 |
| 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) |
08/27/13 |
| 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) |
04/06/12 |
| Guidance for Industry: Preparation of IDEs and INDs for Products Intended to Repair or Replace Knee Cartilage (PDF - 157KB) |
12/01/11 |
| Distribution of In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only - Guidance for Industry and FDA Staff (PDF - 195KB) |
11/25/13 |
| 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) |
04/13/11 |
| Humanitarian Device Exemption (HDE) Regulation: Questions and Answers - Guidance for HDE Holders, Institutional Review Boards (IRBs), Clinical Investigators, and FDA Staff (PDF - 562KB) |
07/08/10 |
| Guidance for Industry and FDA Staff: In Vitro Diagnostic (IVD) Device Studies - Frequently Asked Questions (PDF - 352KB) |
06/25/10 |
| Inspection by Accredited Persons Under The Medical Device User Fee and Modernization Act of 2002 and the FDA Amendments Act of 2007; Accreditation Criteria - Guidance for Industry, FDA Staff, and Third Parties (PDF - 367KB) |
08/06/09 |
| Manufacturer's Notification of the Intent to Use an Accredited Person under the Accredited Persons Inspection Program Authorized by Section 228 of the Food and Drug Administration Amendments Act of 2007 (FDAAA) - Guidance for Industry, FDA Staff, and FDA-Accredited Third Parties (PDF - 249KB) |
03/02/09 |
| Modifications to Devices Subject to Premarket Approval (PMA) - The PMA Supplement Decision-Making Process - Guidance for Industry and FDA Staff (PDF - 200KB) |
12/11/08 |
| Bundling Multiple Devices or Multiple Indications in a Single Submission - Guidance for Industry and FDA Staff (PDF - 439KB) |
06/22/07 |
| Pharmacogenetic Tests and Genetic Tests for Heritable Markers - Guidance for Industry and FDA Staff (PDF - 66KB) |
02/09/06 |
| Real-Time Premarket Approval Application (PMA) Supplements - Guidance for Industry and FDA Staff (PDF - 82KB) |
04/28/06 |
| 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) |
04/25/06 |
| Significant Risk and Nonsignificant Risk Medical Device Studies - Information Sheet (PDF - 211KB) |
01/01/06 |
| Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices - Guidance for Industry and FDA Staff (PDF - 165KB) |
05/11/05 |
| Premarket Approval Application Modular Review - Guidance for Industry and FDA Staff (PDF - 213KB) |
11/03/03 |
| Assessing User Fees: PMA Supplement Definitions, Modular PMA Fees, BLA and Efficacy Supplement Definitions, Bundling Multiple Devices in a Single Application, and Fees for Combination Products - Guidance for Industry and FDA (PDF - 272KB) |
02/25/03 |
| The Least Burdensome Provisions of the FDA Modernization Act of 1997: Concept and Principles - Final Guidance for FDA and Industry (PDF - 226KB) |
10/04/02 |
| General Principles of Software Validation - Final Guidance for Industry and FDA Staff (PDF - 367KB) |
01/11/02 |