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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)
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02/21/18
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Guidance for Industry and Food and Drug Administration Staff - Acceptance and Filing Review for Premarket Approval Applications (PMAs) (PDF - 551KB)
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01/30/18
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Guidance for Industry and Food and Drug Administration Staff - Refuse to Accept Policy for 510(k)s (PDF - 1.9MB)
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01/30/18
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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)
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01/16/18
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Medical Device Accessories - Describing Accessories and Classification Pathways - Guidance for Industry and FDA Staff (PDF - 449KB)
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12/20/17
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Technical Considerations for Additive Manufactured Medical Devices - Guidance for Industry and Food and Drug Administration Staff (PDF - 803KB)
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12/05/17
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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)
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12/05/17
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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)
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12/12/17
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Unique Device Identification: Direct Marking of Devices - Guidance for Industry and Food and Drug Administration Staff (PDF - 587KB)
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11/17/17
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De Novo Classification Process (Evaluation of Automatic Class III Designation) - Guidance for Industry and Food and Drug Administration Staff (PDF - 139KB)
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10/30/17
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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)
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10/25/17
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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)
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10/25/17
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User Fees and Refunds for Premarket Approval Applications and Device Biologics License Applications - Guidance for Industry and Food and Drug Administration Staff (PDF - 513KB)
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10/02/17
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User Fees and Refunds for Premarket Notification Submissions (510(k)s) - Guidance for Industry and Food and Drug Administration Staff (PDF - 118KB)
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10/02/17
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User Fees for 513(g) Requests for Information - Guidance for Industry and Food and Drug Administration Staff (PDF - 83KB)
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10/02/17
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User Fees and Refunds for De Novo Classification Requests - Guidance for Industry and Food and Drug Administration Staff (PDF - 419KB)
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10/02/17
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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)
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10/02/17
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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)
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10/02/17
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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)
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10/02/17
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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)
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10/02/17
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Developing and Responding to Deficiencies in Accordance with the Least Burdensome Provisions - Guidance for Industry and Food and Drug Administration Staff (PDF - 440KB)
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09/29/17
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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)
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09/12/17
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Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices - Guidance for Industry and Food and Drug Administration Staff (PDF - 421KB)
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09/06/17
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Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices - Guidance for Industry and Food and Drug Administration Staff (PDF - 537KB)
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08/31/17
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FY 2018 Medical Device User Fee Small Business Qualification and Certification - Guidance for Industry, Food and Drug Administration Staff and Foreign Governments (PDF - 329KB)
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08/29/17
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Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities - Questions and Answers Guidance for Industry and Review Staff (PDF - 609KB)
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01/18/17
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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)
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01/13/17
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Postmarket Management of Cybersecurity in Medical Devices - Guidance for Industry and Food and Drug Administration Staff (PDF - 1.2MB)
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12/28/16
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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)
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08/30/16
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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)
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08/24/16
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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)
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08/24/16
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Adaptive Designs for Medical Device Clinical Studies - Guidance for Industry and Food and Drug Administration Staff (PDF - 587KB)
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07/27/16
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Leveraging Existing Clinical Data for Extrapolation to Pediatric Uses of Medical Devices - Guidance for Industry and Food and Drug Administration Staff (PDF - 367KB)
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06/21/16
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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)
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01/21/16
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eCopy Program for Medical Device Submissions - Guidance for Industry and Food and Drug Administration Staff (PDF - 525KB)
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12/03/15
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Global Unique Device Identification Database (GUDID): Data Submission Compliance Date of September 24, 2015 - Guidance for Industry and FDA Staff (PDF - 199KB)
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08/14/15
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Balancing Premarket and Postmarket Data Collection for Devices Subject to Premarket Approval - Guidance for Industry and Food and Drug Administration Staff (PDF - 500KB)
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04/13/15
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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 - 800KB)
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04/13/15
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Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling - Guidance for Industry and Food and Drug Administration Staff (PDF - 805KB)
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03/17/15
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Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices - Guidance for Industry and Food and Drug Administration Staff (PDF - 650KB)
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02/09/15
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Mobile Medical Applications - Guidance for Industry and Food and Drug Administration Staff (PDF - 1.3MB)
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02/09/15
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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)
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12/02/14
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Design Considerations for Devices Intended for Home Use - Guidance for Industry and Food and Drug Administration Staff (PDF - 523KB)
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11/24/14
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Molecular Diagnostic Instruments with Combined Functions - Guidance for Industry and Food and Drug Administration Staff (PDF - 425KB)
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11/12/14
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Content of Premarket Submissions for Management of Cybersecurity in Medical Devices - Guidance for Industry and Food and Drug Administration Staff (PDF - 324KB)
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10/02/14
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Evaluation of Sex-Specific Data in Medical Device Clinical Studies - Guidance for Industry and Food and Drug Administration Staff (PDF - 941KB)
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08/22/14
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Unique Device Identifier System: Frequently Asked Questions, Vol. 1 - Guidance for Industry and Food and Drug Administration Staff (PDF - 462KB)
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08/20/14
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FDA Decisions for Investigational Device Exemption Clinical Investigations - Guidance for Sponsors, Clinical Investigators, Institutional Review Boards, and Food and Drug Administration Staff (PDF - 631KB)
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08/19/14
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Unique Device Identification System: Small Entity Compliance Guide - Guidance for Industry and Food and Drug Administration Staff (PDF - 420KB)
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08/13/14
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In Vitro Companion Diagnostic Devices - Guidance for Industry and Food and Drug Administration Staff (PDF - 159KB)
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08/06/14
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The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)] - Guidance for Industry and Food and Drug Administration Staff (PDF - 844KB)
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07/28/14
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Global Unique Device Identification Database (GUDID) - Guidance for Industry and Food and Drug Administration Staff (PDF - 2.8MB)
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06/27/14
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Providing Information about Pediatric Uses of Medical Devices - Guidance for Industry and FDA Staff (PDF - 177KB)
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05/01/14
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Types of Communication During the Review of Medical Device Submissions - Guidance for Industry and FDA Staff (PDF - 134KB)
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04/04/14
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Premarket Assessment of Pediatric Medical Devices - Guidance for Industry and FDA Staff (PDF - 162KB)
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03/24/14
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Annual Reports for Approved Premarket Approval Applications (PMA) - Guidance for Industry and Food and Drug Administration Staff (PDF - 95KB)
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02/10/14
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Design Considerations for Pivotal Clinical Investigations for Medical Devices - Guidance for Industry, Clinical Investigators, Institutional Review Boards and FDA Staff (PDF - 402KB)
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11/07/13
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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)
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10/01/13
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IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites, and the Determination of Whether an IND/IDE is Needed
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08/27/13
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Radio Frequency Wireless Technology in Medical Devices - Guidance for Industry and FDA Staff (PDF - 139KB)
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08/14/13
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Guidance for Industry: Oversight of Clinical Investigations - Risk-Based Approach to Monitoring (PDF - 163KB)
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08/06/13
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Heparin for Drug and Medical Device Use: Monitoring Crude Heparin for Quality (PDF - 60KB)
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06/25/13
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Assay Migration Studies for In Vitro Diagnostic Devices - Guidance for Industry and FDA Staff (PDF - 1.2MB)
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04/25/13
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Medical Device Classification Product Codes - Guidance for Industry and Food and Drug Administration Staff
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04/11/13
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Financial Disclosure by Clinical Investigators (PDF - 165KB)
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02/01/13
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Humanitarian Use Device (HUD) Designations - Guidance for Industry and FDA Staff (PDF - 141KB)
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01/24/13
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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)
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08/27/13
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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)
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04/06/12
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Guidance for Industry: Preparation of IDEs and INDs for Products Intended to Repair or Replace Knee Cartilage (PDF - 157KB)
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12/01/11
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Distribution of In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only - Guidance for Industry and FDA Staff (PDF - 195KB)
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11/25/13
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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)
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04/13/11
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Humanitarian Device Exemption (HDE) Regulation: Questions and Answers - Guidance for HDE Holders, Institutional Review Boards (IRBs), Clinical Investigators, and FDA Staff (PDF - 521KB)
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07/08/10
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Guidance for Industry and FDA Staff: In Vitro Diagnostic (IVD) Device Studies - Frequently Asked Questions (PDF - 352KB)
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06/25/10
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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 - 321KB)
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08/06/09
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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 - 203KB)
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03/02/09
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Modifications to Devices Subject to Premarket Approval (PMA) - The PMA Supplement Decision-Making Process - Guidance for Industry and FDA Staff (PDF - 200KB)
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12/11/08
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Bundling Multiple Devices or Multiple Indications in a Single Submission - Guidance for Industry and FDA Staff (PDF - 439KB)
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06/22/07
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Pharmacogenetic Tests and Genetic Tests for Heritable Markers - Guidance for Industry and FDA Staff (PDF - 66KB)
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02/09/06
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Real-Time Premarket Approval Application (PMA) Supplements - Guidance for Industry and FDA Staff (PDF - 82KB)
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04/28/06
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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)
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04/25/06
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Significant Risk and Nonsignificant Risk Medical Device Studies - Information Sheet (PDF - 211KB)
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01/01/06
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Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices - Guidance for Industry and FDA Staff (PDF - 165KB)
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05/11/05
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Premarket Approval Application Modular Review - Guidance for Industry and FDA Staff (PDF - 213KB)
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11/03/03
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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)
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02/25/03
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The Least Burdensome Provisions of the FDA Modernization Act of 1997: Concept and Principles - Final Guidance for FDA and Industry (PDF - 186KB)
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10/04/02
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General Principles of Software Validation - Final Guidance for Industry and FDA Staff (PDF - 367KB)
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01/11/02
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