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 In this section:

                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          Withdrawn or Expired Guidance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)
          Draft Medical Device GuidanceGuidance Documents (Medical Devices and Radiation-Emitting Products) Draft Medical Device Guidance
  
  	
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Draft Guidance Documents

Title
			Issued DateCharacterization of Metallic Coatings and/or Calcium Phosphate Coatings on Orthopedic Devices - Draft Guidance for Industry and Food and Drug Administration Staff
			12/23/24510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review - Draft Guidance for Industry, Food and Drug Administration Staff, and Third Party Review Organizations
			12/21/23Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices
			12/19/23Select Updates for the 506J Guidance: 506J Device List and Additional Notifications - Draft Guidance for Industry and Food and Drug Administration Staff
			11/17/23Electronic Submission Template for Medical Device De Novo Requests - Draft Guidance for Industry and Food and Drug Administration Staff
			09/29/23Medical Devices with Indications Associated with Weight Loss - Clinical Study and Benefit-Risk Considerations - Draft Guidance for Industry and Food and Drug Administration Staff
			09/14/23Medical Devices with Indications Associated with Weight Loss - Non-Clinical Recommendations - Draft Guidance for Industry and Food and Drug Administration Staff
			09/14/23Evidentiary Expectations for 510(k) Implant Devices - Draft Guidance for Industry and Food and Drug Administration Staff
			09/07/23Recommendations for the Use of Clinical Data in Premarket Notification [510(k)] Submissions - Draft Guidance for Industry and Food and Drug Administration Staff
			09/07/23Best Practices for Selecting a Predicate Device to Support a Premarket Notification [510(k)] Submission - Draft Guidance for Industry and Food and Drug Administration Staff
			09/07/23Clinical Considerations for Studies of Devices Intended to Treat Opioid Use Disorder - Draft Guidance for Industry and Food and Drug Administration Staff
			07/28/23Patient-Matched Guides to Orthopedic Implants - Draft Guidance for Industry and Food and Drug Administration Staff
			06/28/23Marketing 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
			04/03/23Orthopedic Non-Spinal Bone Plates, Screws, and Washers - Premarket Notification (510(k)) Submissions - Draft Guidance for Industry and Food and Drug Administration Staff
			03/29/23Photobiomodulation (PBM) Devices - Premarket Notification [510(k)] Submissions - Draft Guidance for Industry and Food and Drug Administration Staff
			01/12/23Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers - Draft Guidance for Industry and Food and Drug Administration Staff
			12/09/22Computer Software Assurance for Production and Quality System Software - Draft Guidance for Industry and Food and Drug Administration Staff
			09/13/22Laser-Assisted In Situ Keratomileusis (LASIK) Lasers - Patient Labeling Recommendations
			07/28/22Remanufacturing of Medical Devices - Draft Guidance for Industry and Food and Drug Administration Staff
			06/24/21Feasibility and Early Feasibility Clinical Studies for Certain Medical Devices Intended to Therapeutically Improve Glycemic Control in Patients with Type 2 Diabetes Mellitus - Draft Guidance for Industry and Food and Drug Administration Staff
			05/20/21Review and Update of Device Establishment Inspection Processes and Standards - Draft Guidance for Industry
			03/29/19Clarification of Radiation Control Regulations For Manufacturers of Diagnostic X-Ray Equipment - Draft Guidance for Industry and Food and Drug Administration Staff
			12/17/18Process to Request a Review of FDA's Decision Not to Issue Certain Export Certificates for Devices - Draft Guidance for Industry and Food and Drug Administration Staff (PDF - 208KB)
			08/17/18Peripheral Vascular Atherectomy Devices - Premarket Notification [510(k)] Submissions - Draft Guidance for Industry and Food and Drug Administration Staff (PDF - 400KB)
			07/27/18Medical Product Communications That Are Consistent With the FDA-Required Labeling - Questions and Answers Guidance for Industry (PDF - 458KB)
			06/12/18Investigational IVDs Used in Clinical Investigations of Therapeutic Products - Draft Guidance for Industry, Food and Drug Administration Staff, Sponsors, and Institutional Review Boards (PDF - 731KB)
			12/18/17Acceptance Review for De Novo Classification Requests - Draft Guidance for Industry and Food and Drug Administration Staff (PDF - 1MB)
			10/30/17Principles for Codevelopment of an In Vitro Companion Diagnostic Device with a Therapeutic Product - Draft Guidance for Industry and Food and Drug Administration Staff (PDF - 1.1MB)
			07/15/16List of Highest Priority Devices for Human Factors Review - Draft Guidance for Industry and Food and Drug Administration Staff (PDF - 359KB)
			02/03/16Selection of the Appropriate Package Type Terms and Recommendations for Labeling Injectable Medical Products Packaged in Multiple-Dose, Single-Dose, and Single-Patient-Use Containers for Human Use (PDF - 113KB)
			10/21/15Assessment of Radiofrequency-Induced Heating in the Magnetic Resonance (MR) Environment for Multi-Configuration Passive Medical Devices - Guidance for Industry and Food and Drug Administration Staff (PDF - 394KB)
			03/22/16Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs) - Draft Guidance for Industry, Food and Drug Administration Staff, and Clinical Laboratories (PDF - 312KB)
			10/03/14FDA Notification and Medical Device Reporting for Laboratory Developed Tests (LDTs) - Draft Guidance for Industry, Food and Drug Administration Staff, and Clinical Laboratories (PDF - 565KB)
			10/03/14Class II Special Controls Guidance Document: In Vitro Diagnostic Devices for Yersinia spp. Detection - Draft Guidance for Industry and Food and Drug Administration Staff
			11/07/11Presenting Risk Information in Prescription Drug and Medical Device Promotion (PDF - 933KB)
			05/27/09Draft Guidance for Industry, Clinical Laboratories, and FDA Staff - In Vitro Diagnostic Multivariate Index Assays
			07/26/07

                                                                                  Content current as of:
      01/22/2024
              
              
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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